FDA warns Canadian firm for hostile behavior during inspection, two Indian facilities for GMP issues

The US Food and Drug Administration (FDA) recently issued three warning letters to companies in Canada and India for various violations of good manufacturing practice (GMP) violations tied to the production of sterile drugs, OTC products and solid oral dosage forms.

In a warning letter sent to Brand International Corporation, located in Ontario, Canada on 17 December, FDA detailed several egregious issues, including limiting and obstructing an inspection in violation section 501(j) of the Federal Food, Drug, and Cosmetic Act. The company makes a product called Kissable Oatmeal Moisturizing Lotion.

The trouble began on the second day of the inspections when investigators went to the laboratory to meet with the quality control supervisor. The quality manager entered the laboratory and “exhibited hostility by shoving and shouting at our investigators for conducting the inspection without their presence. Laboratory staff refused to open a drug stability chamber based on his hostile behavior.”

Investigators were further “intercepted multiple times” by the quality manager while attempting to ask questions of quality staff by the Quality Manager. While requesting drug product testing specifications from the QC supervisor, the quality manager “interrupted and stated that only he can explain and answer the requests.”

After investigating customer complaints, inspectors discovered positive mold samples for the lotion. During an interview with an employee regarding the positive mold results, the quality manager entered the room and began “berating the employee, who then left the room, impeding FDA’s review of your contamination investigation required under CGMP.”

The company also failed to adequately test incoming active pharmaceutical ingredients (APIs) before using them in drug products and released APIs for use based on its supplier’s certificates of analysis (COAs) without establishing the reliability of the test.

Another violation was the firm’s failure keep the facility clean and free of pests. Investigators observed truck trailers on the property used to store components and finished products that were not climate controlled, including APIs, which were stored outdoors. Pest traps inside the raw material storage area “were covered with filth and insects, and reports from your pest control service provider showed an ongoing pest issue.”

FDA placed the firm’s products on Import Alert following the inspection in October 2024.

Viatris warned for data integrity issues

FDA also warned Viatris, Inc. for multiple violations uncovered during an inspection of its Mylan Laboratories Limited facility in Indore, India last June. The violations concerned overarching issues related to data integrity in the site’s testing of solid oral drugs. Viatris was established through the merger of Mylan and Upjohn in November 2020.

According to a company statement, following the inspection, 11 products have been placed on an Import Alert; however, four products will continue to be available in the market due to concerns about drug shortages.

Investigators raised issues with how the firm tests components after finding “anomalies” in four worksheets that reported passing results for identification testing. FDA noted that access records at the site showed that responsible analysts were not physically present at the facility during testing, so it is unclear who conducted the testing. “Despite their absence, they documented both the testing process and results as if they had conducted the analyses,” FDA wrote.

FDA reminded the firm that “data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends.”

FDA also took exception to the company’s testing programs, their investigations into discrepancies “lacked adequate scientific rationale to support root cause determinations.”

FDA said workers at the plant mishandled the testing by aborting the high-performance liquid chromatography (HPLC) sample without providing adequate justification.

Indoco warned for repeat violations

Indoco Remedies, a manufacturer based in Goa, India, received a warning letter after FDA investigators discovered numerous manufacturing violations related to its production of a sterile solution.

After an inspection in mid-July, investigators reported that the company did not have sufficient controls in place to ensure the reliability of its microbiological testing results. For instance, they observed "numerous non-viable dark particles" on the filters. Additionally, the media plates did not have the smooth surfaces required to promote the growth of microbiological organisms.

The company also did not conduct adequate airflow studies, which FDA said was a problem found in a prior 2023 inspection.

Warning Letters: Brands, Viatris, Indoco

FDA warns Canadian firm for hostile behavior during inspection, two Indian facilities for GMP issues

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