Packaging audit readiness under the FDA regulatory framework is very important to manufacturers, distributors, and brand custodians alike. Good preparation for audits enhances compliance with regulations, ensures the safety of products, protects consumers, and safeguards brand reputation. Inadequate packaging controls or documentation may provoke a regulatory action, product recalls, or impairment to consumer trust. From a regulatory oversight perspective, packaging is not an afterthought but integral to how a product is controlled, labeled, stored, and ultimately delivered to the user.
The FDA governs the process of packaging, product-contact materials, closure systems, labeling, and traceability of packaging operations for foods, dietary supplements, cosmetics, and medical devices. Understanding the approach of the FDA to the inspection of packaging systems and related requirements allows the organization to minimize the risk of enforcement action and maintain market access.
Purpose and scope of packaging audits
For medical devices, the FDA’s Quality System Regulation, under 21 CFR Part 820, governs the design, manufacture, packaging, labeling, storage, installation, servicing, and other controls for “finished devices”. Under 21 CFR 820, packaging is explicitly included within the scope of manufacturing and quality system controls.
Food and dietary supplement product packaging and labeling operations are subject to CGMP requirements. For dietary supplements, this includes “packaging or labeling operations” as part of the manufacturing chain under 21 CFR Part 111. For human food, activities of packing and holding are subject to regulations through CGMPs (21 CFR Part 110 or modernised to Part 117) along with FDA inspection programmes.
In other words, packaging audits investigate whether the materials, processes, controls, and documentation around packaging/labelling support safety and integrity and whether they comply with applicable regulations.
Types of FDA Packaging Audits
The FDA uses several types of inspections from the perspective of packaging and manufacturing operations:
Routine or surveillance/scheduled inspections, which are conducted periodically in the absence of an event-specific trigger. For example, the FDA explains that for food establishments, the inspection process may be routine, targeted, or for-cause.
Preapproval or premarketing inspections: In some cases, such as for medical devices, the FDA inspects the manufacturing facilities of such products before or during the submission/approval stage to ensure the readiness and compliance of systems.
For‐cause audits (triggered inspections) — initiated when the FDA receives information of risk, such as complaints, outbreaks, recall, material deviation, or other signal of noncompliance. For food packaging, for example, the FDA uses such inspections when there is a specific issue.
Typical audit steps
The FDA typically follows this order when performing a packaging audit:
Opening meeting – The FDA investigator(s) introduce themselves, present credentials, issue Form FDA 482 (Notice of Inspection) if domestic, and outline the scope of the inspection.
Facility tour/process walk-through –Investigator observes packaging operations, materials receiving and handling, storage of packaging/closures, label controls, packaging machine processes, line changeovers, closure integrity checks, etc. In food packaging inspections, the device Inspectors review the flow, control of packaging materials, and equipment sterilization (if applicable).
Closing meeting – The investigator shares preliminary observations with the management. The discussion covers immediate issues, next steps, and a request for a written response if necessary.
Issuance of observations and regulatory actions – After the inspection, the FDA may issue Form 483 (Inspectional Observations), request corrective action responses, and, depending on the severity, may issue Warning Letters, recalls, or non‐compliance notices.
Form FDA 483 Inspectional Observations: This aisa a list of the inspectional observations noted by the FDA investigator(s) during an inspection. It is not a final agency determination but requires a response.
Warning Letter: Formal FDA correspondence indicating that certain regulatory violations have been determined and specific corrective action is required; usually, failure to respond may result in enforcement.
Recall: An action taken to remove or correct marketed products that are in violation or pose a risk to health. A recall may be initiated for defects or mistakes in packaging, or for labelling errors.
Non‐compliance notice/enforcement action: FDA may exercise any number of its authorities under law to detain, refuse imports, issue injunctions, or impose administrative penalties when compliance is not realized.
Documents and Records You Need
For the following categories of documentation and records, the documents should be well organized, updated, and available for review to conduct a successful packaging audit:
Packaging specifications – Records exist which define the packaging material requirements, such as closure integrity, barrier properties, compatibility with product, ingress/egress protection, migration or extractables, etc. Supplier material specification sheets, CoAs, food-contact substance notifications, and change control records are critical. Example – The FDA regulates “Food packaging & other substances that come in contact with food” under its food packaging programme.
Labelling records – Records shall be maintained for product labels, mock‐ups, artwork proofs, regulatory reviews, digital approvals, print runs, lot/serial tracking of labels, label change control, and linkages between label and product batch. For dietary supplements, 21 CFR 111 requires specifications for packaging and labels (see § 111.70(d)) and examination of packaging and labels (§ 111.160).
Records of validation and testing: Where required (for example, for sterile or barrier packaging of medical devices, or aseptic packaging of food), records should be on file of sterilization validation, packaging integrity tests, barrier/permeation studies, extractables/leachables, closure torque or seal strength tests, migration tests, and shelf‐life studies. For food packaging, inspection guidance puts an emphasis on documenting container/closure evaluation, production deviations, sterilisation of packaging materials, and integrity.
Supplier qualification documents – Evidence of audits of suppliers, certificates of compliance, traceability of lots of packaging materials back to suppliers, materials change notifications, raw material testing results, and supplier performance records. Under dietary supplement CGMP 21 CFR 111, a packaged or labelled transplant product shall meet packaging specifications under § 111.70(f).
Internal audit logs and corrective actions-Records of internal packaging audits, nonconformity logs, corrective and preventive action records, change control registers, packaging‐material deviations, root cause investigations, and evidence that audit findings were addressed. Under medical device QSR 21 CFR 820, internal audits and management review are required.
Records of employees’ training who are engaged in packaging and labeling – Documentation of training, retraining, competency evaluation for personnel responsible for packaging operations, label changeovers, receiving of packaging materials, maintenance of packaging equipment, clean‐room handling, where applicable, and line changeover protocols. Dietary supplements, 21 CFR 111.1,2, require that personnel have education, training, or experience to perform their assigned functions.
The availability, clarity, and accessibility of these documents help FDA auditors understand that packaging operations are under control and traceable within applicable regulations.
How to Internal Audit the Packaging Process
Step 1: Map the Entire Packaging Workflow
Chart every step in the packaging process from receipt of raw materials through preparation and packaging operations to labeling, sealing or closure, and shipment of the finished product. Mapping should include
Incoming materials, including packaging substrates, closures, and labels, and the procedure for their handling, storage, and release.
Packaging machine set up, line changeovers, inspection stations, and process controls.
Labelling operations: artwork verification, placement, font checks, and lot/serial coding
Final packaging/closure operations, including tamper-evident seals, secondary packaging, and shipping containers.
Finished goods storage and dispatch process, including traceability.
A visual workflow helps identify points where controls should be applied, where records must exist, and where risk may be highest-for example, at changeover or label application.
Step 2: Identify Critical Control Points (CCPs)
Within the mapped workflow, identify points that pose the most significant regulatory, safety, or quality risk. Examples of CCPs in packaging would include:
Sterilization processes or validated barrier packaging: To the extent a medical device or other product is required to be sterile, packaging shall maintain sterility to the point of use. The medical device inspection program guidance helps to underscore controls needed over sterilization and packaging for devices.
Barrier integrity or seal strength testing: For example, that a package prevents the ingress/egress or migration of contaminants.
Label accuracy and proper placement: labelling errors are a very common cause of regulatory observations. Documents like the FDA’s “Packaging and Labeling” guide to drugs provide examples of label and packaging material controls.
Tamper-evident seals or other closure controls. If product safety depends on tamper evidence, then the closure and sealing of products must be verified.
Lot/batch traceability for product and packaging materials, including the packaging lot number, label batches, and supplier identification.
Identify for each CCP what control exists, such as inspections, testing, verification, and how this is recorded.
Step 3: Conduct Internal Mock Audits Using FDA-style Checklists
Use internal or external checklists matching applicable regulations example, for devices 21 CFR Part 820 or for packaged products under CGMP. FDA’s “Guide to Inspections of Quality Systems” under Part 820 provides an indication of what inspectors are looking for.
Conduct mock opening meetings, review key records, such as packaging specifications, change control, machine logs, label records; perform a walk of the facility as if an auditor were there; and conduct a closing meeting in which findings and next steps are summarized.
Document findings of the mock audit in a formal way: list observations, classify the severity/risk, assign corrective action plans, timing, responsible persons, and track.
Review readiness of personnel for an actual inspection: Are appropriate staff trained? Are records easily retrievable? Are the key procedures current? The preparedness article on FDA inspections emphasizes “a constant state of readiness” rather than ad hoc preparation. The FDA Group
Step 4: Traceability Systems Verification and Batch/Lot Documentation
Records of the supplier lot number of packaging materials-films, pouches, closures, and labels-and the link to lots or batches of the product.
Ability to trace which label version was used on which batch of production and which lot of packaging material.
Change control records when packaging material or label artwork is changed.
Records of storage, issuance, and use of packaging/label materials (quantities, dates, locations). FDA’s Packaging & Labeling guide to pharmaceuticals also emphasizes these aspects of the use and storage of materials.
Records for finished goods would include: lot/serial number of package, packaging machine identification, operator identification, packaging date/time, quantity finished, and records of inspection and release.
Step 5: Check that packaging, labeling, and documentation are in accordance with all FDA requirements
This is the process of checking that all packaging materials, labels, and related documentation meet the relevant FDA regulations and internal quality system controls. Key aspects include:
Labels shall follow the regulatory requirements of font size, layout, placement, required warnings, device identifiers, and nutrition facts, etc. If the product is a medical device, packaging and labelling shall follow 21 CFR Part 820 and related device labelling regulations. The FDA Quality System Inspection Guide describes inspection of labelling and packaging under production and process controls.
Certain specified physical or chemical properties are required of the packaging materials, including barrier performance, compatibility with the product, and shelf life stability. Internal specifications should exist, be approved, and controlled.
There is documentation that procedures and specifications are current. Examples include: change control logs are current to show approval of any packaging or label changes; obsolete labels or packaging are removed from use; records are maintained for required periods.
Storage conditions for packaging and labels: store labels so as to avoid damaging or fading of ink; store packaging materials in a way that they cannot be contaminated or damaged by moisture.
Machine setup logs, packaging line inspections, such as visual package inspection/integrity and seal check, shall be reviewed along with the records of release by the firm for finished product packaging.
Regular checks will confirm these items to maintain the packaging process in conformity with regulatory expectations and internal commitments related to the quality system.
Common Red Flags in FDA Packaging Audits
During packaging or manufacturing inspections, a specific set of recurring problems appears as audit findings or regulatory observations. Awareness of these red flags helps in focusing internal audits and readiness programs.
Lack/insufficient documentation for packaging materials: for example, supplier CoAs for packaging films are not available, and material specifications have not been formally approved. The list of Warning Letters published by the FDA points to this as a very common problem.
Labels bearing false, unreadable, or obsolete information. Labeling errors are a common root cause of enforcement actions. Very common examples of labeling-related enforcement actions include those for inadequate warnings, incorrect net contents, and version control errors.
Inadequate records of sterilization or barrier integrity testing. As an example, for devices or for aseptic/sterile products specifically, the lack of any validation or periodic determination of packaging integrity is considered to be a serious deficiency. Emphasis has been placed by the Inspection of Medical Device Manufacturers program on packaging controls, including sterilization and packaging/closure systems.
Non-compliance of a supplier or lack of traceability: If the packaging supplier is not qualified, records of supplier audit are missing, and packaging lot tracking is incomplete, then this is a vulnerability.
Poor record keeping, incomplete internal audits, or untrained personnel. If an internal audit programme is weak, an audit finding is not tracked to closure, or employees performing packaging or labelling do not have documented training, these are common findings in Warning Letters. It’s expected that effective CAPA systems should be documented, verified, and validated according to FDA CAPA guidance.
Observed deviations from regulations such as 21 CFR Parts 111 (dietary supplements), 820 (devices), or 101 (food labelling). For example, a device packaging process might show packaging materials in uncontrolled storage contrary to Part 820’s production and process controls. The Compliance Program manual emphasizes that these regulations provide the inspection baseline.
These early-identified red flags enable corrective actions to be taken well in advance of any official FDA inspection and minimize the risk of receiving either a Form 483 or a Warning Letter.
Post Audit Corrections and Best Practices
Internally and externally, wherever the audits on packaging have identified issues or observations, proper follow-through should be implemented. Response to findings, improvements, and ongoing control follows next.
Responding to 483 Observations or Internal Audit Findings
When a Form 483 (Inspectional Observations) is issued by the FDA, or internal audit findings are identified:
For each observation, prepare a response plan that covers the root cause investigation, correction, prevention, name of the responsible person, and timeline for closure. For correctly implementing the corrective and preventive measures, the FDA guidance on CAPA has some specific expectations.
Verify the corrective actions taken: Performing the action itself is not enough; documentation needs to prove that it has been effective and that non-reoccurrence is ensured. Retraining by itself is not enough unless performance measures reflect the improvement.
Communicate and document management review of significant nonconformities; ensure linkage to change control, supplier control, or process improvement as needed.
Preventive measures and system strengthening
More than corrective action, the principle of sustainable improvement embeds prevention and control into the core of day-to-day operations.
Update SOPs on packaging, labelling, storage, machine changeover, traceability, and training to reflect current best practice and regulatory requirements.
Retrain personnel: Make sure people involved in packaging, labelling, material handling, and verification are trained, document competencies, and schedule refreshers.
Improve documentation practices to maintain the proper access, completeness, legibility, and retention of records concerning packaging specifications, label change records, and supplier audits within the prescribed period.
Monitor supplier performance through the maintenance of qualification files for suppliers, conducting periodic audits of packaging material suppliers, tracking supplier nonconformances, monitoring lead times, defect rates, and change notification performance.
Validate or revalidate packaging changes, where the packaging materials or labels change-material, artwork, and supplier. Validate packaging performance: barrier, seal, and migration; lot traceability; and provide associated documentation.
Continuous Monitoring and Record Retention
Sustained compliance depends on monitoring and the retention of key documentation:
Internal Audits: Schedule periodic reviews of the packaging process, quarterly or semiannual audits, and monitor open items for closure.
Periodic review of packaging metrics, to include but not be limited to the following: yield for packaged units, label misapplication rates, packaging scrap or rejects, supplier material deviations, and shipment complaints related to packaging.
Record retention: depending on the type of regulation, packaging and labeling records generally must be retained for at least 2 to 5 years, but often much longer. For example, the Pharmaceutical Packaging & Labeling guide under 21 CFR 211 details storage of material examination records, although the specific retention could be tied to the product.
Internal CAPA trending review: recurrence analysis for packaging non-conformances, determination of the effectiveness of root cause, and management review of packaging operation
Upcoming Trends to Watch
Against a shifting regulatory landscape and growing consumer expectations, there are several key trends that will determine how packaging audits and compliance will be managed in the near future.
Digital Record Keeping and Smart Packaging Audits
The shift from paper-based documentation toward digital systems is becoming increasingly pronounced. Regulations such as 21 CFR Part 11 recognize that electronic records and signatures may be used in place of traditional paper-based ones, provided controls around integrity, traceability, audit trail, and security are met.
By applying validated digital record-keeping systems, packaging operations can realize faster document retrieval, easier version control, and better readiness for audits. For example, when databases for packaging specifications, label version histories, training logs, and machine change-over records are in a secure electronic system, audits can be done with less risk of missing documentation and greater efficiency.
In fact, intelligent packaging audits—using mobile devices or tablets for online checklists, recording photographs or video of packaging line activities, and linking directly to training or deviation records—are increasingly practical.
This trend means that packaging compliance programs have to take into consideration IT system validation, electronic records governance, security of access, and audit trail visibility.
QR Code and Blockchain Traceability for Supply Chain Transparency
Traceability has been a long-standing regulatory requirement in packaging and labeling operations, but the means of attaining it keep changing. Using QR codes, NFC tags, or other machine-readable identifiers on packaging can enable more complete and accurate visibility of material origin, lot/serial number, packaging component version, line identification, and distribution channel.
Some companies deploy a blockchain-based ledger system that captures material flow data—for example, packaging substrate lot arrival, supplier certificates, material issuance, label version usage, finished good packaging lot, and shipment—in a tamper-evident system.
This kind of traceability enhances the documentation stack that an auditing authority, such as the FDA, may look at, especially where there are suspect or affected materials, label changeovers, supplier changes, or recalls.
These technologies, while not yet formally mandated in all regulated sectors, improve readiness, enhance transparency, and may be used as a differentiator for manufacturing and brand operations.
Eco-friendly Packaging Considerations & FDA Compliance Checks
Sustainability and “green packaging” have become key drivers in brand and regulatory strategy. For instance, the FDA guidance document Use of Recycled Plastics in Food Packaging (Chemistry Considerations): Guidance for Industry recognizes that chemical contaminants from recycled materials could migrate into food and outlines risk control approaches.
Key considerations for eco-friendly packaging include:
Verification that the supplies of recycled material are appropriately characterized and approved for food contact.
Conducting migration/extractables/leachables testing as needed.
Documentation of the recycling process.
Supplier certification and traceability.
Substantiation that label claims (“made with recycled content”, “compostable”) are verified and meet general labeling requirements under 21 CFR.
Besides, when packaging substrates are evolving (bio-based resins, compostable films, novel coatings), the validation of barrier properties, interaction with the product, shelf-life stability, and regulatory acceptance becomes of the highest importance.
Auditors increasingly review not only “traditional” packaging systems but also eco-innovated packaging, ensuring that sustainability claims do not compromise safety or compliance.
Conclusion
In summary, stringent preparation for packaging audits secures tangible benefits: reduction of regulatory risk, prevention of enforcement actions, and protection of brand credibility.
Packaging operations should be set within a robust compliance ecosystem—validated packaging materials, well-controlled labeling changes, strong supplier qualification, traceability systems, internal audits, and corrective/preventative actions.
Meanwhile, new emerging developments such as digital recordkeeping, QR/blockchain traceability, and eco-friendly packaging bring both opportunities and compliance considerations.
Furthermore, long-term business growth is based on product integrity and consumer safety through consistent adherence to FDA regulations.
One Comment