FDA 483 Letter – FDA Warning Letter

FDA 483 is the auditor observations of violations from GMP observed at the time of inspection. FDA inspector will discuss each 483 observation with the management at the time of closing meeting. If any response at the time of discussion is convincing, FDA auditor may remove that observation from 483 letter. Generally, the FDA 483 Letter response time is fifteen working days, but if you get a specific period from FDA inspector you should respond within the specified time.

If the violations are significant or may cause serious injury or death, FDA will issue waring letter. Generally, FDA will issue warning letter only after review the 483-response letter and found the response is not complete or not include a corrective and preventive action plan. Each warning letter will state a specific time to send the reply, usually the response time for warning letter is ten or fifteen working days.

An experienced quality system/ GMP consultant can help you to develop or correct necessary documents for closing FDA 483 Letter or warning letter. GMP implementation or update require frequent consultant visit and discussions, so it is better to select a consultant who is easily reachable.

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