FDA warning letters flag GMP violations, false advertising of drugs

The US Food and Drug Administration (FDA) sent warning letters throughout April to three companies for current good manufacturing practice (cGMP) violations for finished pharmaceuticals, including failure to ensure glycerin safety, dirty facilities, and inattention to out-of-limit microbial results. In May, the agency cited a pharmaceutical company for false or misleading promotions of a prescription diuretic.

Hollywood’s Product Society gets glycerin safety check

The Product Society of North Hollywood received a warning letter from FDA’s Center for Drug Evaluation and Research (CDER) on May 8 about GMP violations related to safety testing of glycerin ingredients in over-the-counter (OTC) drugs for topical and oral use.

The Product Society bills itself as a full-service brand development and turnkey manufacturing partner for nutrition and personal care companies. According to the firm’s website, partners sell their goods via major retailers like Amazon, Walmart, and Sephora.

The letter follows an inspection carried out from 18-27 November 2024 and a response on 20 December that was not enough to allay FDA’s concerns. According to the agency, the company failed to test samples of each component for identity and conformity. The company also reportedly failed to establish reliability of suppliers’ tests of components, instead relying on partners’ certificates of analyses.
Testing for glycerin and certain other high-risk components should ensure limits are not exceeded for diethylene glycol (DEG) and ethylene glycol (EG), hazardous impurities that can result in lethal poisoning, the letter explained. The letter also notes that the company’s water system is not being adequately monitored, as well as quality control lapses. FDA also noted the products may be regulated as cosmetics and need to be in line with new compliance requirements of the Modernization of Cosmetics Regulation Act of 2022.

“We acknowledge your commitment to case production of all OTC drugs and that you deregistered your facility as a drug manufacturer,” FDA wrote. “In response to this letter, clarify whether you intend to resume manufacturing drugs for the U.S. market at this facility in the future.”

The company was given 15 working days to respond.

Sarfez dinged for Rx diuretic promotions, post-ACC

Sarfez Pharmaceuticals, of Vienna, Austria, was sent a warning letter 25 April regarding false claims in promotional materials for its slow-release loop diuretic Soaanz (torsemide), which is used to treat edema related to heart failure or kidney disease.

The letter followed a visit by the agency’s Office of Prescription Drug Promotion (OPDP) representatives to the company’s promotional exhibit booth at the American College of Cardiology (ACC) annual meeting, held 6-8 April.

According to the letter, the OPDP takes issue with an ACC exhibit booth panel, a pamphlet on display for distribution at the booth, and corresponding website pages about the product, claiming they make false or misleading claims about efficacy and provide insufficient information.

The promo materials suggest that the slow-release Soaanz formulation does not cause excessive or abrupt urination compared to generics and is specially formulated for patients whose bladder symptoms get worse with the use of a loop diuretic. However, these claims are not supported by evidence submitted to FDA, according to the letter.

Soaanz has multiple contraindications and warnings and precautions and is typically used by vulnerable populations with complex, debilitating medical conditions, FDA noted.

The company was given 15 working days to respond to the letter and provide evidence supporting promotional claims.

Dead bugs signal risk at Wuxi Medical Instrument Factory

Wuxi Medical Instrument Factory of the Jiangsu province in China was sent a letter on 4 April regarding GMP violations observed in an inspection 11-15 November 2024 at a manufacturing facility in Wuxi. According to the letter, drugs were prepared, packed or held in “insanitary” conditions, risking contamination with filth and health hazards. The firm responded to concerns on 5 December 2024, but this was deemed inadequate.

The letter cites many insanitary issues resulting in adulterated products including “numerous dead insects inside the tubing” used to transfer the active pharmaceutical ingredient from storage to drums; “multiple pieces of unknown debris” in processes for products labelled as sterile; and bulk with hair, unknown particulates, or insects.

FDA also observed that since a prior inspection, the company discontinued its sterilization process without implementing a new procedure.

“Furthermore, your firm lacked a procedure for conducting environmental monitoring during manufacturing operations and failed to ensure operators adhered to proper gowning requirements, thereby compromising the sterility assurance of [REDACTED] labeled as sterile,” the letter went on to say.

The company issued a voluntary recall of sterile products due to a lack of sterility assurance and GMP violations on 11 February, based on a recommendation from the FDA. The agency had placed an import hold on the company’s products on 21 January.

Wuxi Medical Instrument Factory was asked to respond to the latest letter within 15 working days.

NWL Netherlands Services exceeds microbial limits

NWL Netherlands Services received a warning letter 1 April for significant GMP at the company’s drug manufacturing facility in Zuid-Holland, the Netherlands.

The letter followed an inspection 14-18 October 2024 and subsequent response 8 November, which was deemed adequate.

According to the letter, the company failed to thoroughly investigate discrepancies or failures of a batch or any of its components, including repeated out-of-limit results for microbial content in a manufacturing system.

“In 2024, you obtained seven OOL events, at least two with results as high as 10,000 colony -forming units (CFU/mL),” the letter states.

At a minimum, the facility must meet US standards for appropriate microbial limits, the FDA wrote. Among other violations, the letter also flagged failure to perform identity testing of each component lot used in production of OTC drug products. If the company fails to address violations, the US may refuse admission to products from the Zuid-Holland facility, the FDA warned.

The company was given 15 working days to respond.

Product Society, Sarfez Pharmaceuticals, Wuxi Medical Instrument Factory Co., NWL Netherlands Services

FDA warning letters flag GMP violations, false advertising of drugs

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