April 17, 2012
WASHINGTONInadequate cleaning, equipment, specifications, batch and master manufacturing records, quality control personnel and product labeling categorized the numerous good manufacturing practice (GMP) violations FDA noted in it's warning letter to Theta Brothers Sports Nutrition Inc., a Lakewood, NJ-based dietary supplement manufacturer. The agency asked for a response from the company within 15 days of receipt of the letter, detailing steps taken to correct the many violations.
The failures listed in the letter were extensive. FDA said processing equipment was not adequately cleaned to prevent contamination, including from egg, milk and other allergens. Inspectors also noted the company did not use equipment appropriately designed to prevent contamination, citing the use of inadequate commercial-grade stock (soup) pots and handheld mixers for mixing powder blends. The company also failed to record and keep documentation of calibration of instruments or equipment used in manufacturing.
According to the letter, the company also failed to establish specifications for components, as well as for identity, purity, strength, and composition of some of the dietary supplement products manufactured at the facility. The company also failed to determine any established specifications were met during manufacturing, including specifications for finished batches. In fact, the letter noted requirements for batch records were not followed, as the company did not prepare batch records for each batch of manufactured product and the batch records they did create were inadequate and incomplete. Some master manufacturing records (MMRs) were also incomplete and not followed.
In addition to these violations, Theta Brother also did not establish written procedures in numerous GMP areas, including identification of each unique lot of each shipment; there was no identifier used to record each lot of components either shipped or manufactured. Written procedures were also not established to outline the responsibilities of quality control operations, including material review, disposition decisions and approving/rejecting reprocessed material. There also were no written procedures for review of product complaints by a qualified personprocedures supplied by the company for handling complaints were not specific to the operations at the facility.
The company failed to set specifications for its dietary supplement labels, but several other labeling violation caused certain products to be misbranded, according to FDA. Several products failed to contain proper allergen warnings, while others, including a product called Anabolic Cream, failed to denote on the label the product is a dietary supplement. Some products used a "Nutrition Facts" panel instead of the required "Supplement Facts" panel, some labels were missing key information in the Suplpement Facts panel, and other labels did not follow the proper Supplement Facts format. In other labeling, there was inadequate or missing information for place of business and/or responsible party.
FDA added information on several other serious GMP violations, including failure to create and keep documentation on training and education of personnel involved in manufacturing, packaging, labeling, holding or quality control functions. The agency further said inspectors found the company's Protein Factory Zip product contains an undeclared and unsafe ingredient, desiccated thyroid gland extract.
Read the full warning ltter to Theta Brothers here.
INSIDER's Take: This letter indicates this company met only a bare minimum of GMP requirements and has long way to go before it is GMP compliant. Inadequate records can be expected on some level, but the industry has beating the drum of "records, records, records" and "If it isn't written, it didn't happen" for years now. The documentation and records failures listed are quite extensive. If records are a source of common failure across first GMP inspections, contamination problems should not be common, at least not to the level indicated in this letter. Given the frequent accusation the supplement industry is plagued by adulteration and contamination, supplement companies should be expending all efforts to ensure they control and minimize contamination risk. This letter provides a look at a company that summarily failed at this task. Further, FDA noted in several places in the letter that the company's response to various violations were inadequate. As many regulatory experts in industry GMP educational events have noted, inadequate and delayed response to GMP inspection violations (as noted in a 483 report from FDA) is sure to generate a warning letter. It will be interesting to see how the company handles this situation and how FDA escalates it enforcement.
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