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FDA Form 483: Minimizing FDA Inspection Citations

By W. M. Huitt W. M. Huitt Co. |

As an owner or manager of a company whose product is regulated by the U.S. Food and Drug Administration (FDA), you will, at some point, be subjected to an FDA inspection. And once an inspection is underway in your facility, anything affecting the drug or food product directly or indirectly in an adverse manner is within the purview of the FDA inspectors. If discrepancies are found during such an inspection, one or more Form 483 Inspectional Observation Forms will be submitted to company management addressing each discrepancy. These will come at the conclusion of the inspection process, and each discrepancy will be discussed and explained. Keeping in mind that the majority of discrepancies will typically be subjective in nature, they can be wide-ranging in their impact and implication — from a housekeeping issue to product adulteration. Form 483 is used by the FDA as a first step in correcting a product-related deficiency within a facility. Deficiencies can be related to computer programming, product-contact material of construction, procedural issues, material handling, documentation, and on and on. Anything, as mentioned earlier, that could affect the consistent and acceptable quality of the product is fair game. Rather than…
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