Becoming an FDA regulated Outsourcing Facility (503B) can be a daunting task. Pay the registration fee, wait for the inspector, and then hold onto your hat! It's like you are back at Pharmacy school and learning a new language, cGMPs, part 11, what does the FDA mean by "appropriate", do they really mean I have to do that?
Thus far the vast majority of initial (and subsequent re-inspections) have resulted in the issuance of a Form 483. Understanding what to expect in an FDA inspection process and what is included in the cGMPs can make a difference in the inspection outcome. Performance Validation has been assisting the life science industry since 1988, and has a limited number of pocket compliance guides available FOR FREE, simply complete the registration form below and we will send you the pocket guide and some information about Performance Validation and the services we offer.
Please note this offer is limited to organizations registered as or contemplating registering as a 503B Outsourcing Facility with USFDA only.
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