The warning letter dated August 13, 2012 was sent to John Parrillo, owner of Ohio-based Parrillo Performance, for a failure to “comply with the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements”, following an audit of the company’s facilities in February.
“These violations cause the dietary supplement products manufactured and packaged at your facility to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. 342(g)(1)] in that they have been prepared, packed or held under conditions that do not meet the CGMP regulations for dietary supplements.”
Following the February audit, the company was issued with an FDA 483. FDA received a response from the company on March 21, 2012.
“Although you state in your response that you are working to address all of FDA’s concerns, you failed to provide detailed information and documentation that would assist us in evaluating whether you have implemented the necessary corrections. Therefore, your response is inadequate.”
Actions speak louder than words
In response to the letter, the American Herbal Products Association (AHPA) noted in a legal alert that “Telling FDA you are fixing the problems is not enough.
“FDA says ‘show us,’ as demonstrated in this language from the warning letter: ‘We have reviewed your response and we find it inadequate because you have not provided any documentation to indicate that you have corrected any of the deficiencies observed during your inspection,’” said AHPA.
The list of alleged violations included:
- A failure to establish component specifications
- A failure to conduct ingredient identity testing (“Specifically, your firm did not test or verify the identity of any dietary ingredients used in your products,” reads the letter).
- A failure to establish written quality control procedures
- A failure to prepare and follow a written master manufacturing record (MMR) for each dietary supplement formulation
- A failure to follow the requirements for batch production records
- A failure to make and keep records to fulfill the requirements related to components, packaging, and labels, and for products received for packaging and labeling as a dietary supplement, as required by 21 CFR 111.180(a). Specifically, you have not made or kept receiving records for components, as required by 21 CFR 111.180(b)(2).
- A failure to establish and follow written procedures to fulfill the requirements related to packaging and labeling operations
- A failure to establish and follow written procedures to fulfill the requirements related to holding and distributing operations
- A failure to follow staff personal hygiene practices,
Several other issues were highlighted by FDA. For a complete listing, please click here.