The U.S. Food and Drug Administration (FDA) has issued four new warning letters to pharmaceutical manufacturers in the U.S., Canada, and China for significant violations of current good manufacturing practices (CGMP) and for illegally marketing unapproved drug products.

Apotex: Sterility and Quality Control Failures

Canadian generic drugmaker Apotex received a warning letter following an inspection of its Ontario facility. FDA cited the company for repeated failures to investigate leaking sterile containers—at least eight leak failures occurred from 2023 to 2025 without proper root-cause analysis. Inspectors also found equipment deterioration, discolored gloves, unknown stains, and particle buildup in sterile manufacturing areas.
The company temporarily halted production of certain sterile solutions and sprays and issued several recalls, including ophthalmic solutions and lacosamide oral solution. FDA gave Apotex 15 days to address the violations.

Scientific Protein Laboratories: Risk of Particulate Contamination

At Scientific Protein Laboratories in Wisconsin, FDA inspectors found scratched and grooved equipment surfaces that could contaminate active pharmaceutical ingredients. The agency also criticized the company’s inadequate investigations into deviations, including an unsupported root-cause conclusion regarding assay failures in thyroid powder.

Taizhou Kangpin (China): Lack of Sterility Assurance

Chinese manufacturer Taizhou Kangpin received a warning letter for failing to maintain proper sterility controls for its single-use prep pads, such as alcohol and iodine swabs. FDA noted the absence of adequate procedures, specifications, and testing methods. The company has said it will stop selling OTC products in the U.S. beginning March 2025.

IBSPOT (U.S.): Unapproved Drug Claims

Pennsylvania-based IBSPOT.com was warned for marketing motion-sickness patches containing undisclosed active ingredients, including diphenhydramine and diclofenac. FDA said the products made unapproved drug claims, including relief from nausea, dizziness, and other travel-related symptoms.