The FDA has issued warning letters to two U.S. dietary supplement makers and a Hong Kong drugmaker — already under import alert in the U.S. — for significant cGMP violations over adulterated products and data integrity issues.
Nutraloid Labs, of Kingston, N.Y., and Perfect Water and Essentials LLC, of Salt Lake City, Utah, were found with manufacturing, packaging, labeling and holding operation violations for their dietary supplements.
The FDA determined that Nutraloid failed to have written procedures for a host of issues, including quality control procedures, training, returned dietary supplements, product complaints, holding and distributing operations, as well as proper cleaning of its facilities and pest control.
Written Procedures Missing
Nutraloid’s products — Humoloid-HGH, Tribuloid Testosterone Boost and Groloid — lacked identification in that the labels fail to identify the part of the plant from which each dietary ingredient is derived, and the serving size is incorrect. The Jan. 8 warning letter said Nutraloid’s label is misbranded, and it doesn’t bear a domestic address or phone number.
The owner, Bartholomew A. Panessa, tells DGR that the FDA’s action was the result of a misunderstanding with a company contractor and agency procedures. “It had nothing to do with the quality of the product,” he says. “The matter is resolved; everything is fine now.”
Perfect Water and Essentials LLC, which also does business as Aquagen International, was issued its warning letter on Dec. 10, stemming from an August inspection. The FDA inspector noted that the dietary supplement company mislabeled its product and failed to perform proper laboratory testing.
While Perfect Water and Essentials issued a response to the FDA inspection, most of the answers were not specific enough. The company also failed to produce proper batch production records, and its written response was inadequate, the FDA said. Perfect Water and Essentials did not respond for comment.
Quality Procedures Lacking
Meanwhile, the Chan Yat Hing Medicine Factory of Kowloon, Hong Kong, was inspected by the FDA from July 6 to 8, 2015, and was placed on import alert on Dec. 3. FDA investigators found that the drugmaker failed to have procedures in place for its quality control unit, and it had no way to check customer complaints or to demonstrate drugs would meet their shelf life, according to the Dec. 15, 2015, warning letter.
The Chan Yat Hing Medicine Factory’s quality unit continually “released multiple batches of drug productions for distribution,” despite failing to test finished batches for identity and strength of active ingredients, the FDA said. The company also failed to ensure the identity of components, including active ingredients and excipients from suppliers.
Moreover, the company did not establish written procedures for production and process controls.
The FDA said it may continue to refuse admittance of Chan Yat Hing Medicine Factory’s products into the U.S. unless it takes corrective action. In addition, the agency may withhold approval of new drug applications or supplements that list Chan Yat Hing Medicine Factory as a drugmaker.
The agency recommended that the company hire a third-party consultant with GMP expertise to assess its facility and overall management system. Chan Yat Hing Medicine Factory could not be reached for comment.
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