The FDA’s Denver district director, Thomas Warwick, wrote to John Carroll, chief executive officer, Hain North America, listing eight areas where management practices at the firm’s dietary supplement manufacturing facility at Boulder, Colorado violated GMP rules.
The violations, noted during an inspection in early April, covered the products: Ginseng Energy, Detox A.M., Echinacea Complete Care, Sleepytime Extra, Sleepytime Throat Tamer, and Tummy Mint herbal tea products.
Specific criticisms included failure to:
- Prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement and for each batch size, to ensure uniformity in the finished batch from batch to batch.
- Keep batch production records (BPR) that included complete information relating to the production and control of each batch of specified products.
- Establish required specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR.
- Comply with requirements for laboratory operations.
- Maintain an adequate quality control program.
- Collect samples of each unique lot of packaging and labels.
- Routinely calibrate, inspect, or check the equipment to ensure proper performance and quality control personnel periodically failed to review these calibrations, inspections, or checks.
- Ensure that each person engaged in the manufacturing, packaging, labeling or holding, or in performing any quality control operations, has the education, training, or experience to perform the person’s assigned functions.
Carroll was required to advise the FDA’s Denver office in writing within 15 days of receiving the letter that steps have taken to correct the violations and to supply supporting documentation.
Neither Carroll nor a colleague was available to comment on the FDA’s warning letter.
Enforcement
But New York-based food attorney Marc Ullman told NutraIngredients-USA.com that the FDA appears to use GMP Warning Letters as much for education as for enforcement.
In general, companies that receive these letters take the matter seriously and provide FDA with a description of the corrective actions that will be taken, he said.
However Ullman questioned the effectiveness of warning letters sent to those companies that appear to believe compliance with the GMPs are optional.
RockHard Weekend
Meanwhile, Atlanta-based RockHard Laboratories has recalled voluntarily the company’s dietary supplements sold under the brands RockHard Weekend and Pandora.
The recall covers Lot Numbers: RockHard Weekend Lot Numbers: 100159 and 100260 sold as blister packs, 3ct bottles and 8ct bottles and Pandora Lot Numbers: 100378 sold as blister packs.
Independent testing found that the above lot numbers contain an analogue of sildenafil; an FDA-approved drug used as treatment for male erectile dysfunction (ED). The active drug ingredient is not listed on the label for these products.
Using the products may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs such as nitroglycerin.
It may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.