In the aftermath of an FDA site inspection resulting in unsatisfactory findings, the company in question faces a difficult situation that must be addressed quickly to avoid serious consequences. If not properly addressed, negative observations made during an FDA visit can ultimately result in suspended operations, bad press, scrupulous monitoring of operations, recall of products, and warning letters. Fortunately, the process followed by the FDA is intended to allow most companies operating out of compliance to remediate their practices and continue operation in an acceptable manner. Although the remediation process tends to be hectic and unpleasant, it can actually be beneficial for a company because if done correctly, the remediation will result in higher quality business practices.
At the conclusion of an FDA site visit, the inspectors will issue an FDA Form 483 if there are observations. A 483 lists detailed observations of any issues the inspectors consider to be in violation of the Federal Food, Drug, and Cosmetic Act and related acts (The Act). The inspectors will discuss all observations with the company’s senior management, explaining in detail why they consider each observation to be a violation of The Act, and what specific regulations they believe are being violated. The company is encouraged (although it is not mandatory) to respond to the FDA with a written plan for Corrective and Preventative Action (CAPA), and begin executing that plan “expeditiously.” It is important to note that a 483 is not a final determination by the FDA that a company is operating out of compliance, but rather the inspector’s notification that they believe such to be the case, and that remedial action will be necessary. After reviewing the 483 with company management, the FDA inspector will return the 483 and any other evidence documentation to the FDA for further review. These reviews can result in the FDA issuing the company a Warning Letter, or even mandating a suspension of company operations.
When reviewing inspection reports that contain such a 483, the FDA takes many factors into consideration, including the company’s response to the 483. Generally, any CAPA plan and a summary of any execution of that plan already underway can be submitted to the FDA within 15 days of a 483 being issued, and the FDA will evaluate such submissions during review of the site inspection. In some cases the FDA may find that such responses on the part of the company are sufficient to remedy the situation, and will not even issue a Warning Letter.
Since all documents must be submitted to the FDA within 15 days of receiving a 483 to be considered during the site inspection review, a company must act quickly to draft their response. In this critical time frame, the advice and assistance of knowledgeable industry experts can be invaluable in creating a comprehensive CAPA plan that not only fully addresses all issues raised in the 483, but is practical and cost effective. Globiox’s compliance specialists have in-depth knowledge of the FDA’s structure and workings, and extensive experience in remediating compliance issues raised by FDA inspectors.