FDA issues blitz of warning letters over testing violations and refusing records requests

The US Food and Drug Administration (FDA) sent warning letters to ten foreign over-the-counter drugmakers for failing to test raw materials susceptible for Diethylene Glycol (DEG) and Ethylene Glycol (EG) contamination; some of these letters also took the companies to task for ignoring the agency’s requests for written records. FDA also handed two warning letters to domestic drugmakers for failure to comply with requests for records.

Of the ten letters that cited testing violations, four went to firms in India, including Daxal Cosmetics, Skyline Herbals, Suhan Aerosol and Orchid Lifesciences; three were issued to companies in South Korea, including LCC Limited, Sangleaf Pharm, and KM Pharmaceuticals. One letter went to Portugal-based Fancystage Unipessoal, one went to Canadian firm Avaria Health and Beauty Corp, and one was sent to Turkish firm Tan Alize Kozmetik.

FDA used the same boilerplate language in many of these warning letters, stating that “the use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide.”

FDA has long-standing concerns with DEG and EG poisoning, which served as a catalyst for the creation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). On the international front, in the 1990s, DEG poisonings occurred in Argentina, Bangladesh, Haiti, India and Nigeria. More recently, WHO issued a health alert in January, amid reports of contaminated cough syrups containing DEG and EG, which were linked to 300 deaths in three countries last year, with most of the fatalities occurring in children. (RELATED: WHO proposes updated excipient GMPs in wake of contaminated cough syrup, Regulatory Focus 10 April 2023)

Failure to respond to requests for records prompted two warning letters to OTC drugmakers in Texas, Cergomex Imports and GTP International. All 12 warning letters were posted on 8 August. Since the COVID-19 pandemic disrupted the agency’s ability to conduct in-person inspections, the agency has carried out record requests under section 704(a)(4) of the FD&C Act. Despite the lifting of travel restrictions as the world has transitioned out of the emergency phase of the pandemic, FDA continues to conduct record requests as part of its surveillance operations.

Testing violations and record refusals

Four companies were cited for testing problems and refusal to grant a request by FDA for written records, including Daxal, which makes toothpaste. The letter stated that “ingredients of the drugs registered as manufactured at your firm include ingredients susceptible to Diethylene Glycol (DEG) and Ethylene Glycol (EG) substitutes.”

FDA also reminded the firms that “the use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide.” And referred the companies to its May 2023 guidance Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol.

Several of the firms also refused FDA’s requests for records. The agency reminded those firms that “it is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)) to refuse to permit access to or copying of any record as required by section 704(a).”

Three other firms were cited for both testing and records request refusals: KM Pharmaceuticals which manufactures hand sanitizers; and Skyline and Sangleaf, which produces toothpaste.

Products from all four companies were placed on an import alert.

Other firms that receiving warning letters for testing lapses included Fancystage Unipessoal, Avaria, LCC, Tan Alize Kozmetik, Orchid and Suhan Aerosol.

Failure to respond to records requests

Two Texas-based firms, Cergomex and GTP International, which both manufacture hand sanitizers, refused to comply with FDA’s request for records.

The Cergomex warning letter states that “we made multiple attempts to contact you by phone on August 1, 2023. Those attempts were unsuccessful, and we were unable to leave a voice message. You failed to respond to these attempted communications or otherwise provide the requested records or other information. Pursuant to section 704(a)(4), FDA’s request and follow-up communication included a sufficient and clear description of the records sought.”

Warning letters: Skyline, Cergomex, Daxal, GTP, Fancystage, Avaria, LCC, Suhan Aerosol, KM Pharmaceutical, Orchid Lifesciences, Tan Alize Kozmetik, Sangleaf

FDA issues blitz of warning letters over testing violations and refusing records requests

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