August 21, 2012
WASHINGTONFDA has sent a warning letter to John Parrillo and his bodybuilding supplement company Parrillo Performance concerning the numerous GMP violations found by agency inspectors in February 2012. The agency warned Parrillo the violations render the company's dietary supplements made at the inspected facility to be considered adulterated. In the letter, FDA told the company its response to the 483 inspection report was inadequate because it only promised corrective action without providing detailed documentation indicating corrective action was actually taken.
The GMP violations listed in the warning letter are extensive, including failure to establish specifications and written procedures for various aspects of the facility's manufacturing, packaging and labeling, as well as failure to conduct required testing, including identity confirmation. Parrillo did not establish or follow a master manufacturing record (MMRs) for each unique product; it also failed to follow batch record procedures, which were missing required information on equipment identity, maintenance/cleaning/sanitation records, documentation showing finished product meets specs, and key signatures and identifiers at crucial points in the processing, packaging and labeling of the products. There were also noted deficiencies in the company's quality control personnel activities documentation, receiving records for components, procedures and adherence for product complaint and returned products, hygiene and conduct of personnel relative to contamination potential, calibration and inspection of equipment, and cleaning and pest control of the entire facility.
FDA highlighted the company's failure to hold reserve samples for one year beyond shelf life (for those products bearing a shelf life statement) for two years from the date of distribution of the last batch of dietary supplements associated with the reserve samples. These are important for investigations and are required by the GMP regulation.
Calling the company's initial response to the 483 report inadequate, FDA gave Parrillo 15 working days from receipt of the letter, which is dated Aug. 13, to respond adequately with information on steps taken to correct these violations. FDA said any delay in correcting the violations needs to be explained in the response, accompanied by a statement of when the corrections will be made. The first warning letter to Parrillo over these GMP violations was sent in June 2012.
Given the lengthy list of violations that span many aspects of supplement manufacturing, it appears Parrillo either did not take the regulation seriously or failed to utilize all the industry resources available to them for educational and preparation purposes. Fifteen days is not a lot of time to catch up on the regulation's finer points and/or self-correct such extensive failures, so it is possible the most viable corrective avenue for Parrillo is to enlist expert consultants in what amounts to a super-rush job of bringing the company into compliance. This can't be cheap. The only other alternative is to farm out the manufacturing to a reputable contract manufacturer. At any rate, this GMP failure is not helping the industry's image, especially a bodybuilding segment often questioned over responsibility, safety and quality concerns.
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