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FDA Warning Letter: If a Company Finds Other Areas of Remediation, Should They Communicate Them to FDA?

You do not need to communicate other areas of remediation to the FDA immediately. For instance, if you have a nine month plan and a couple months into it you find an area that you need to correct and a couple months after you find another area that you will remediate that wasn’t part of an initial finding either, you do not have to communicate all of that back to the FDA. But, in your final report or your final statement back to the FDA you may want to include that information. Including your own findings shows that you are doing your own due diligence and that you have your own internal controls in place.

USDM had a large client that had some 483s around some computer systems validation. Part of the plan was to investigate the root cause and within that was a plan to look at all of their automated systems and find out the levels of validation, if there was any validation. We found many systems the investigator didn’t look at that were not validated. We corrected the specific automated system in ERP as part of the investigation but in our final statement to the FDA we included that we addressed other areas where we found a lack of validation.

USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.


  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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