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FDA Waring Letter: What if a Company Needs More Time to Remediate a Problem?

We can all estimate times and we have all been through projects that don’t end on the date or time expected. As long as you communicate, you will be fine. If you have committed to a particular date on your 30-day response to a warning letter and you find that while you are remediating you need more time, you must communicate to the FDA. It’s not uncommon to have an initial timeline in place and then find you need additional time. You will be fine as long as you explain why you need more time, what the new time frame will be, and what the new risk factors involved are.

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.