483 and Warning Letter Response and Remediation

When a 483 is issued at the end of an FDA inspection a clock starts ticking for the time to formally respond to the 483s in writing.  The company has 15 working days from the issue of the 483 at close of inspection, not after official written notice after the inspection, to formally address the 483s.

Take These Critical Steps

Complete Response

The response must address each of the items that are cited in the individual 483s and address the systems that these 483s originated from to give context to the proposed responses and to define the scope of remediation that is proposed.

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