The US Food and Drug Administration (FDA) conducts regular inspections of regulated pharmaceutical finished dose and active pharmaceutical ingredients (API) to determine whether the manufacturing facility is compliant to the guidelines set forth by the USFDA.
At the end of each inspection, the UDFDA inspectors issue an FDA Form 483 to notify the facility’s management of observations on any conditions that in the inspectors’ judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. These non-compliant conditions or practices in turn would indicate that any food, drug, device or cosmetic being prepared, packed, or held under conditions has been altered or is/are at a great risk to become altered or rendered hazardous to health.
Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement the same expeditiously. It’s important to respond to the FDA Form 483 within 15 daysas early response is necessary in order to avoid a warning letter.
The key to successfully dealing with such observations by the FDA inspectors is to always remain in a state of inspection readiness. More often than not, companies become complacent and fall back into bad habits. It is not only important that an organization has an inspection readiness team available at all times but also one that is well trained with how to effectively and efficiently respond to the queries raised by the FDA inspector. This will allow them to waste no time in collecting data and develop thoughtful and meaningful responses to the FDA.
Various resources such as, 483sOnline.com can help address the above to help you become better equipped to tackle FDA inspections and the subsequent observations. This pre-investigation intelligence tool can help you identify exactly what investigators are focusing on so you can get ready for those issues – before the investigator shows up!
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