Responding to 483s – Avoiding a Warning Letter
It may be suprising when the FDA shows up to inspect your facility. It’s important tow work with the FDA agent but feel free to ask for counsel. If possible correct items the agent identifies during the plant tour. This will show an eagerness to voluntary comply and can help avoid a Warning Letter. After an inspection expect to received a Form 483. Officially, the FDA Form 483 is referred to as “Notice of Inspectional Observations.” The 483 is issued by the FDA field investigator after an on-site inspection and lists deficiencies in your quality system. The observations contained in every Form 483 are based on the inspector’s interpretation of the regulations as they relate to your operational GMP quality system.
The field inspector will submit the finalized 483 to their superiors; based on the severity of the findings, an FDA Warning Letter may be issued to your firm. If the findings don’t warrant a Warning Letter a mishandled 483 Response will.
When an Investigator issues an FDA-483 at the conclusion of a Food and Drug Administration (FDA) inspection, it is always wise to send a written response to the items listed on the 483. There is no rule or law that requires a formal written response to the 483. However, since most firms do send a written response to FDA, it has become an expectation. It’s also important to close the loop, otherwise there is no documentation that corrective actions were taken. Consult with counsel and submit a response as soon as possible.
A number of articles have been written that address the essentials of how to write the response. The single most important way to respond to the 483 is to provide accurate information and to be clear and concise. FDA wants a description of how a deficiency will be corrected – not a historical narrative. Address every finding carefully and remember hiring counsel at this stage can be much less expensive than hiring counsel to respond to a warning letter!
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