FDA issues warning letters for CGMP violations, unauthorized marketing

The US Food and Drug Administration (FDA) has issued several warning letters to drug, biologic, and device manufacturers for failing to meet current good manufacturing practices (CGMP), marketing unapproved products, and inadequately addressing product complaints.

DeVere & CDL

FDA issued warning letters to a couple of over-the-counter (OTC) hand sanitizer companies for failing to maintain current good manufacturing practices (CGMP), including DeVere Manufacturing. Regulators cited the company for failing to have proper written procedures for cleaning and maintaining equipment. They noted that the company used the same equipment for manufacturing hand sanitizers as they did for non-drug products such as industrial cleaning detergents and toilet bowl cleaners.

"Under CGMP, it is unacceptable to manufacture drug products using the same equipment you use to manufacture non-pharmaceutical products due to the risk of cross-contamination," FDA wrote. "Inadequate removal of active ingredients and product residues from surfaces of non-dedicated manufacturing equipment can lead to contamination of drug products subsequently manufactured on that equipment."

DeVere and CDL Services were both cited for failing to have appropriate laboratory procedures to ensure that the final product conformed to specifications. In the case of DeVere, the agency also stated that it failed to have laboratory procedures in place to ensure the final product was free from microbial contamination.

"You failed to conduct adequate finished product release testing for each batch of your hand sanitizer drug products, including but not limited to, testing of the identity and strength of each active ingredient, testing for impurities, and testing for objectionable microorganisms," FDA told DeVere. "You provided records demonstrating that you test your hand sanitizer drug products for [redacted].

"Your records also demonstrate titration, for determination of quaternary ammonium cations in the benzalkonium chloride hand sanitizers," the agency added. "However, in the past two years, you manufactured more than [redacted] batches of hand sanitizer using [redacted] water, which is unsuitable for use as a component of a drug product. You did not perform microbiological testing on those batches made with unsuitable water."

Both hand sanitizer manufacturers were also cited for failing to test samples of each component of their products for identity and conformity, as well as for failing to validate the products of their component suppliers. FDA noted that the ethanol, glycerin, and water used to make the final products were not adequately tested for purity. The agency warned that failure to test the components adequately could lead to contamination with methanol, diethylene glycol (DEG), or ethylene glycol (EG), and/or microbial contamination.

The quality control units at both companies were cited for failing to perform their duties, and FDA recommended seeking assistance from consultants who are knowledgeable in CGMP. DeVere was also cited for similar CGMP violations found in 2018, and it was noted that repeat failures indicated the company's executive management lacked adequate oversight and control of its manufacturing operations.

FDA also raised concerns that its investigators did not have full access during their inspection of CDL in April.

"During the inspection, the gas chromatograph and the associated CGMP computer system were not available to the inspection team," said the agency. "This limited FDA’s access to records for inspection to evaluate the CGMP compliance status of your facility."

Seaway Pharma

Seaway Pharma also received a warning letter for CGMP violations following an inspection conducted earlier this year. The New York-based OTC drug manufacturing company, which produces children's analgesics and cough and cold products, was informed that its quality unit lacked adequate oversight of its manufacturing process and distributed products without reviewing test results to ensure they met final specifications. They were also cited for failing to test the components of their drug products to ensure they did not contain DEG or EG contamination.

Even as a contractor, the FDA told the company they are responsible for the quality of drugs produced at their facility, regardless of any agreements with the company that markets the product.

"Drugs must be manufactured in conformance with CGMP," said the agency. "FDA is aware that many drug manufacturers use independent contractors, such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer."

FDA also noted that the facility in question was previously owned by Kingston Pharma, which received a warning letter in 2019 for similar CGMP violations.

"While there was a subsequent transfer of ownership of the company, the manufacturing facility and multiple responsible officials remained the same," the agency noted. "Repeated failures demonstrated during subsequent inspections conducted in September 2021, September 2023, and June 2025 indicate that executive management oversight and control over the manufacture of drugs are inadequate."

Lux Therapeutics, Celularity & BioXtek

FDA issued warning letters to three manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps) for marketing unapproved products derived from human placental tissue. Lux Therapeutics, Celularity, and BioXtek were all told that since they marketed their products to diagnose, cure, mitigate, treat, or prevent a disease or condition, they needed FDA approval.

While Lux Therapeutics told FDA that it will stop marketing its Luxegen product made from human umbilical cord tissue after 1 December, the agency said it was concerned about the products it had already distributed and asked the company for details on what it intends to do about the products already on the market.

Lux Therapeutics was also cited for failing to validate and approve its manufacturing processes and for not providing a summary of records that list and interpret the results of all communicable disease tests performed on the final product.

Envoy Medical

Envoy Medical, which manufactures the Esteem II implantable hearing aids, also received a warning letter for CGMP violations, specifically related to quality system regulations (QSR). The company was cited for failing to establish and maintain adequate procedures for receiving, reviewing, and evaluating product complaints.

"Specifically, your firm has not adequately implemented your Complaint Handling, Medical Device Reporting and Vigilance Reporting, Document Number 000978, Revision 26, Dated 20-May-2024, to ensure complaints are processed in a uniform and timely manner," said FDA.

FDA listed several examples where the company received reports of an infection, battery depletion, and sensor problems related to the Esteem II implants, but did not complete an investigation of the reports. The agency also cited the company for failing to maintain proper corrective and preventive actions (CAPA) to address manufacturing issues and listed several examples where its CAPA actions were inadequate.

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FDA issues warning letters for CGMP violations, unauthorized marketing

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