How to Deal with a FDA Inspection?

Any manufacturing industry registered with FDA must undergo the “Nerve-Wrecking” FDA audit. In recent years, FDA has conducted frequent audits to make sure that the companies are compliant with the regulations of the Food, Drug and Cosmetic Act. The following steps will help you to handle the whole audit process with ease.

  • Typically, you will get a notification about the inspection from the FDA in case of routine and Pre-Approval inspections. But companies with prior violations are not that fortunate to have this advantage.
  • According to the United States Federal Food, Drug, and Cosmetic Act (FDC) Section 537, An FDA inspector can enter “….at reasonable times, any area in such factory, warehouse, or establishment in which the manufacturer’s tests (or testing programs) required by section 534(h) are carried out…” and refusal to the entry of the inspector is a criminal offence and might lead to penalties.
  • Once the FDA inspector is in your facility, make sure to check the ID and the written notice of inspection.
  • Understand the notification and the purpose of the audit and also explain your company policies if any, which might restrain the inspection process.
  • Keep all your licenses, reports, SOPs and other relevant documents ready, to present to the FDA Inspector.
  • Quality systems is one of the main inspectional element in the audit, and a technical expert or a Process representative from the company is required to demonstrate its compliance to the inspector.
  • The process representative should document the whole audit processes and also provide the FDA inspector with answers for all relevant questions.
  • In case of any cGMP deviation, a Form 483 will be presented and discussed with the management of your company.
  • In this scenario, bring in all the right technical expertise and subject matter experts to resolve the issue. Supposing you don’t have the right resources, do not hesitate to seek outside help. Remember you will only have 15 business days to respond to the Form 483.
  • Compile and submit a thorough and well-constructed response letter, assuring that the concerns have been taken care of and state the measurements taken by your organization to remedy the issues.
  • After the submission make sure you follow up with the FDA officials, to know whether your response is satisfactory to the compliance officer or the investigator.