Food & Drug Administration

There has been a tremendous increase in the number of FDA inspections that have occurred during the past few years. In addition, the level of scrutiny, during a typical inspection, has increased. Is your company ready to face an FDA Inspection?

The FDA issues a Form 483 once they have completed the inspection of a medical device manufacturer’s facility. The FDA Form 483 is officially called a "Notice of Inspectional Observations," commonly referred to simply as a "483."The FDA inspector will submit the final 483 to his/her superiors.

If the findings are serious enough, or if the response to the 483 that you submit is deemed insufficient, an FDA Warning Letter may be issued to your firm. A Warning Letter is the FDA's advisory notice that you have significantly violated FDA regulations. It will identify the violation(s) and make it clear that you must inform the FDA of your specific plans for correcting each of the problem(s), including actions to prevent it or a similar problem from re-occurring. The FDA will check to ensure that the specified corrections are adequate as per the standard. The quality and promptness of your response to their notice/letter are extremely important.

SARACA has significant experience in formulating a proper response to 483s, as well as Warning Letters. We can also provide you with guidance to ensure that your quality system is in full compliance with FDA regulations, as detailed in 21 CFR Part 820.

Saraca has the following unique capabilities to assist Medical Device Manufacturers:

• Provide a Readiness Check prior to an FDA Inspection
• Participate in FDA Inspections with you and your team
• Build a strategy to properly present your QMS and product documentation to the Inspector
• Determine Root Causes and implement appropriate corrective actions after the inspection.
• Prepare the response to a 483 or Warning Letter.

Please reach out to Saraca if you have any questions.