Without question the FDA will continue to aggressively enforce the Current Good Manufacturing Practices regulations set out in 21 CFR Part 111. To understand what the FDA is looking for and finding during dietary supplement GMP inspections, EAS has compiled a summary chart from data released by the FDA summarizing all dietary supplement observations contained in 483s (reports of inspectional observations) during FY 2013 which paints a very clear picture of the dietary supplement industry’s ongoing issues. To receive a copy of this summary, fill out the form below.
We recommend that you review this information and carefully consider whether your quality programs adequately addresses the issues identified by FDA. It is important to note that the second and third most frequent observations relate to the establishment of appropriate specifications for the identity, strength, purity and composition of finished dietary supplements and the failure to confirm that such specifications are met.
Regardless of whether you are a manufacturer, packager, laboratory or a distributer of dietary supplements, including “own label distributors”, you have extensive requirements under Part 111 that must be met in order for you to be compliant. Repeated Warning Letters published by FDA make it clear that many companies still do not understand what procedures, processes, systems and personnel they must have in place to avoid significant FDA 483 observations.
If you have any questions or concerns about your company’s compliance with the Dietary Supplement GMPs, or need assistance in assessing you GMP compliance or implementing acceptable GMP practices and procedures, please contact Dean Cirotta at 571-447-5502 or firstname.lastname@example.org.