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Thank you for attending the FDA warning letter presentation as presented by compliance insight this is a PowerPoint presentation regarding FDA warning letters and a compliance officers guide to surviving the storm if you have any questions with this need any help certainly give us a call five one three eight six zero three five one two, or you can certainly shoot us an email visit our website wwlp.com what is an FDA warning letter the United States FDA defines a warning letter as in quotes a correspondence that notifies a regulated industry about violations that the FDA is documented during its inspections or investigations typically a warning letter notifies a responsible individual or firm that the agency considers one or more products practices processes or other activities to be in violation of the Federal Food Drug and Cosmetic Act Damp;C act it's implementing regulations and other federal statutes warning letters should only be used for violations of regulatory significance i.e. those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected a warning letter is one of the agency's principal means of achieving prompt voluntary compliance the Act why you're receiving an FDA warning letter when you receive a letter like that first indication is that you're shocked while what caused this letter documents a violation of law or regulation it establishes that a firm or person has been notified of that violation and your response to the 43 may have been deficient may be a reason why you've received that letter it's designed to remotely promote voluntary compliance they want you to voluntarily fix your situation the FDA is not there to work for you to make you go along that path they want you to do that voluntarily, and it is certainly a stepping stone for further regulatory action not limited to a consent decree injunction seizures all those types of things can be very, very bad things that happen to you after a warning letter what does this mean for you and your firm you've received a warning letter it's considered to be prior to notice you're put on notice that you're in violation you have to respond within 15 working days get that response back to them as quickly as you can but do it effectively FDA will initiate necessary action if no response is received, and I can tell you the necessary action is not very good time is very critical when you receive a warning letter if you have to organize things you have to understand what the situation is you have to resolve the problems, and then you have to write it up and respond to the FDA before we begin on the response let me say a few words about the assessment of the situation you have to look at what is going on in your firm how things got this far out of control what caused it how did this come about really get an understanding of where you are and how you got that there two approaches to the assessment there's going to be a focused...
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