The United States system of regulation views packaging as much more than an external container; it is a key safety component. For each of its categories of products-food, dietary supplements, cosmetics, over-the-counter drugs, and medical devices-federal law has strict requirements related to packaging and labeling. When packaging fails to meet such requirements, the FDA describes…
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…
In addition to being a means of presenting the product, the packaging of a medical device also plays an important role in patient safety, device effectiveness, and regulatory compliance. It should be one capable of serving as a barrier against outside factors, ensuring sterility and integrity from manufacturing to the user. Poorly designed packaging can…