Don’t forget to check your CMO
AACE Pharmaceuticals in Fairfield, New Jersey was inspected after the FDA found “violative conditions” at CMO Brassica Pharma Private, which manufactures ophthalmic drugs for AACE. Issues at Brassica included “poor aseptic practices for the manufacture of sterile drugs; fabrication of microbiology laboratory records; microbial recoveries of incubating samples from ISO 5 manufacturing areas and sterility tests exhibiting turbidity during incubation; inadequate media fill program and airflow visualization studies; and use of ripped and visibly dirty gowning in the aseptic processing areas.”
Brassica received a warning letter in 2024 and its products were placed on an import alert. AACE has now received its own warning letter. The letter states, “Your quality unit failed to have adequate supplier qualification procedures to ensure that the drug products received from your CMO were manufactured in compliance with CGMP prior to being distributed in the United States.”
FDA investigators found that AACE had identified cGMP deficiencies with Brassica in 2020, but still qualified the company as an approved CDMO. AACE also requalified Brassica in 2023, “without evaluating whether subsequent corrective actions and preventive actions adequately addressed the identified deficiencies.”
Peeling paint in cleanrooms and other aseptic issues
Rechon Life Science AB in Sweden has received a warning letter for issues associated with aseptic processes. Investigators observed an operator touching a product with their gloved hand during set up and assembly of the aseptic line. The letter says, “This unacceptable practice of touching the (b)(4) with gloved hands was permitted in your standard operating procedure (SOP-0870-3.0) for filling and sealing on the ampoule line. For example, your procedure allowed the operator to adjust the (b)(4), “with the fingertip” of a sanitized gloved hand.”
The letter stresses that only sterile instruments should be used for interventions on the aseptic line.
The company was also found to be conducting inadequate investigations into environmental monitoring excursion results and had not validated and assessed decontamination procedures. Peeling paint and rust was also found in cleanroom environments.
Inadequate equipment design
In China, Yiling Pharmaceutical was found to be using non-dedicated equipment that was not properly designed or maintained, increasing the risk of cross-contamination between different drug products. Specifically, certain equipment components did not close tightly, allowing drug residues to accumulate in ducts.
In response, the company said it would test reserve samples for possible cross-contamination. The FDA letter added, “Your response is inadequate. Your assessment is limited to testing reserve samples of each finished drug product only for the presence of the preceding drug substance processed on the same non-dedicated equipment, instead of testing each reserve sample for all drug substances processed on the equipment. You do not adequately address how you intend to maintain this equipment to ensure the integrity of the seals.”
Unapproved and misbranded
Every month, there are always warning letters issued for companies marketing unapproved new drugs. A number of websites received warning letters for selling unapproved and misbranded opioids. Buyprosoma was selling products such as tapentadol, which carries a black box warning. Soma4ever promised medicines, including opioids and ADHD medications, that “are 100% genuine and safe to use. We only sell FDA-approved medications that will make you feel better.” The FDA, however, issued them a warning letter.
Mother Earth Minerals also received a warning letter for promoting the use of calcium, magnesium and silver for diseases such as cancer and multiple sclerosis. The company claimed: “Cancer does not kill as all cancer really is your very own cells that have somehow started to mutate ... This protocol is designed to increase inter-cellular "communication" cycles, and help repair and regenerate "damaged" DNA. Once this happens, cancer cells often return to their "normal" state of existence. This "miracle" is known as "spontaneous regression" - and happens quite often.””
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