FDA issues slew of warning letters for GMP and unapproved drug violations

The US Food and Drug Administration (FDA) recently posted four warning letters to pharmaceutical manufacturers in the US, Canada, and China for violations of current good manufacturing practices (CGMPs) and for marketing unapproved drug products.

The letters were addressed to Apotex, a large Canadian generic drugmaker, a manufacturer of active pharmaceutical ingredients (API) in the US, and two manufacturers located in China and the US.

Apotex criticized for insufficient investigations

FDA sent a warning letter to Apotex on 31 October citing the firm for three violations related to its production of sterile solutions and sprays intended for the US market. The agency inspected Apotex's facility in Ontario, Canada, from April to May 2025.

According to FDA, the company failed to investigate out-of-specification results for leaking containers. The agency said that Apotex failed to investigate at least eight failures for leaks between September 2023 and April 2025.

“Production personnel repeatedly performed leak testing until they obtained passing results instead of investigating the root cause of identified failures,” said the letter.

FDA also found residue on the closure of a stability sample and determined that the root cause was the product formulation being incompatible with the cap liner, as well as inadequate sealing of the cap. This incompatibility led to corrosion of the closure liner, which resulted in product leakage. The FDA noted that even though the company assessed the risk as high risk, no action was taken at the time for products that were distributed in the US.

The FDA stated that Apotex did not adhere to the proper procedures for preventing microbiological contamination in sterile drug products. An investigator discovered numerous cases of deterioration and damage to equipment used in sterile drug manufacturing. The investigator also observed discolored gloves and various stains of unknown origin on the interior surfaces of the equipment, as well as deteriorated gasket seals.

Inspectors also found a buildup of particles on the manufacturing equipment used to produce spray products distributed to the US market.

After the inspection, Apotex temporarily suspended the manufacturing and distribution of sterile solutions and small-volume spray drug products while implementing a corrective and preventive action (CAPA) plan. The company also voluntarily recalled its azelastine HCl ophthalmic solution, ketorolac tromethamine ophthalmic solution, and brimonidine tartrate/timolol maleate ophthalmic solution due to glove breaches that occurred during manufacturing. Additionally, the firm recalled the lacosamide oral solution due to product leakage.

FDA gave the company 15 days to correct the violations noted in the warning letter.

Scientific Protein Laboratories

Scientific Protein Laboratories, an API supplier, received a warning letter posted on 4 November for several violations at its facility in Waunakee, WI. Investigators found that the company failed to ensure that equipment surfaces in contact with raw materials, intermediates, and APIs do not compromise the quality of these substances beyond official or established specifications.

During the inspection, investigators found “numerous grooves and scratches” on the API contact surface, where the company processes organs such as the pancreas, which is used to manufacture pancrelipase. FDA said that these grooves and scratches “may lead to contamination of your API with particulate matter.”

FDA said the company also failed to establish and follow written procedures for investigating critical deviations.

The company’s investigation into assay failures during stability testing of its thyroid powder identified its sampling procedure as the potential root cause. Yet the investigation “did not include sufficient evidence or rationale to support your purported root cause.”

Taizhou Kangpin criticized for lack of sterility assurance

FDA also posted a warning letter to Taizhou Kangpin Medical Science and Technology Center in Taizhou City, China. The company makes a range of sterile, single-use medical prep pads, including alcohol swabs, iodine swabs, and lens wipes, according to its website.

The agency said the company failed to establish procedures to prevent micro-contamination in products purporting to be sterile. FDA investigators also found the company failed to establish appropriate product specifications and scientifically sound testing procedures.

The company said it would no longer commercially sell its OTC products in the US starting in March 2025.

IBSPOT criticized for making unapproved drug claims

FDA’s warning letter reprimanded IBSPOT.com Inc. in Elkins Park, PA for distributing unapproved new drug claims for motion sickness. The products are “Taoscare Motion Sickness Patch” and “Navabelle Motion Sickness Patches” products.

FDA said the products are both unapproved and misbranded contained the ingredients diphenhydramine, diphenhydramine N-oxide, and diclofenac, which were not listed on the product labels.

The labels state that these products act quickly to provide relief from nausea, vomiting, dizziness, anorexia, and other symptoms caused by traveling in cars, ships, planes, trains, and other modes of transport.

Apotex, Scientific Protein Taizhou Kangping, IBSpot

FDA issues slew of warning letters for GMP and unapproved drug violations

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