The U.S. Food and Drug Administration (FDA) recently issued multiple warning letters to pharmaceutical and medical product manufacturers across the United States, Canada, and China for violations involving current Good Manufacturing Practices (cGMP) and unapproved drug marketing. The enforcement actions highlight the agency’s continued emphasis on product integrity, sterility assurance, and regulatory compliance within both domestic and global manufacturing networks.
Apotex: Inadequate Investigations and Sterility Concerns
On October 31, 2025, FDA issued a warning letter to Apotex, a major Canadian generic drug manufacturer, citing deficiencies in the production of sterile solutions and spray products distributed to the U.S. market. The violations were identified during inspections of the company’s Ontario facility conducted between April and May 2025.
FDA noted that Apotex repeatedly failed to investigate out-of-specification (OOS) leak test results, with personnel performing retests until passing results were achieved rather than identifying root causes. The agency also observed residue and corrosion on product closures, linked to formulation incompatibility with cap liners, and evidence of damaged sterile equipment, including discolored gloves, deteriorated seals, and unidentified stains.
Following the inspection, Apotex voluntarily suspended manufacturing and distribution of several sterile products and implemented a corrective and preventive action (CAPA) plan. The firm also initiated multiple recalls, including ophthalmic and oral solutions affected by equipment and glove integrity breaches. FDA has required Apotex to address the violations within 15 business days.
Scientific Protein Laboratories: Equipment and Process Deficiencies
Scientific Protein Laboratories, an API manufacturer based in Wisconsin, received a warning letter dated November 4, 2025, for failing to maintain sanitary manufacturing conditions and adequate deviation investigations. Inspectors observed grooves and scratches on equipment surfaces used to process raw materials such as animal organs for API production, posing a risk of particulate contamination.
FDA also criticized the company’s investigation procedures for incomplete root-cause analyses regarding assay failures during stability testing of thyroid powder products. The agency concluded that the firm lacked adequate evidence to support its conclusions and did not fully address the risk of contamination to its active ingredients.
Taizhou Kangpin: Deficient Sterility Assurance
The FDA also issued a warning to Taizhou Kangpin Medical Science and Technology Center in Taizhou City, China, citing violations related to the manufacture of sterile, single-use prep pads and swabs. Inspectors found that the company failed to establish sterility assurance procedures, quality specifications, or validated testing methods.
In response to FDA findings, the company reported that it would cease commercial distribution of its over-the-counter products, including alcohol and iodine swabs, in the U.S. market beginning March 2025.
IBSPOT.com: Unapproved and Misbranded Drug Products
In Pennsylvania, FDA issued a warning to IBSPOT.com Inc. for distributing unapproved and misbranded motion sickness patches under the brand names Taoscare Motion Sickness Patch and Navabelle Motion Sickness Patches.
The agency found that the products made drug claims without approval, marketing themselves as fast-acting treatments for nausea, dizziness, and vomiting associated with travel. Laboratory analysis revealed undisclosed active ingredients—diphenhydramine, diphenhydramine N-oxide, and diclofenac—which were not listed on product labels, further violating labeling and safety regulations.
The EMMA International Perspective
These recent FDA enforcement actions underscore the agency’s ongoing commitment to strengthening quality oversight and protecting public health. Manufacturers are expected to implement risk-based quality systems, maintain rigorous contamination controls, and ensure accurate product labeling at all stages of production and distribution.
At EMMA International, our experts partner with life-science organizations to address FDA compliance challenges through proactive risk management, CAPA design, cGMP audits, and remediation strategies. Whether resolving warning letters or building robust quality frameworks, EMMA International provides the regulatory and technical expertise needed to achieve lasting compliance.
For more information on how EMMA International can assist, visit www.emmainternational.com or contact us at (248) 987-4497 or info@emmainternational.com.
Reference:
Eglovitch, J. (2025, November 12). FDA issues slew of warning letters for GMP and unapproved drug violations. Regulatory Focus, Regulatory Affairs Professionals Society.
U.S. Food and Drug Administration. (2025). Warning Letters Database.
