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Form 483 Remediation

Posted by Aniket Chaudhari on July 16, 2024 at 5:55am 0 Comments

Medical device manufacturers receive observations (Form 483) and / or warning letters on completion of USFDA Audit. The document outlines any violations of Good Manufacturing Practices (GMP’s) such as the facility, equipment, processes, controls, products, employee practices or records.IZiel has successfully assisted medical device companies to resolve these observations with efficiency and accuracy.

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