The FDA issued a warning letter to Granules India Limited following an inspection of its Telangana-based drug manufacturing facility.
The regulator’s inspection, conducted from Aug. 26 to Sept. 6, 2024, identified significant violations of current Good Manufacturing Practice (cGMP) regulations, leading to concerns over product contamination and facility maintenance. The FDA stated that the firm’s drug products are considered adulterated under the Federal Food, Drug, and Cosmetic Act due to noncompliance with cGMP standards.
Among the key violations, the agency cited inadequate cleaning procedures, leading to microbial contamination and cross-contamination risks in the facility’s air handling units. Investigators found residues from previously manufactured drugs and microbial contamination in air ducts, despite the presence of high-efficiency particulate air (HEPA) filters. Additionally, the facility had not properly maintained its buildings, with bird droppings and feathers discovered in critical manufacturing areas, raising further concerns about product safety.
The FDA also flagged deficiencies in equipment maintenance and calibration, particularly in the company’s air handling systems, which were not adequately inspected to ensure filter integrity. Further, the agency discovered torn cGMP records discarded in waste bags, calling into question the Granules’ data integrity practices.
In response to the violations, Granules provided corrective action plans but the regulator found them to be insufficient, urging the company to conduct a more comprehensive review and implement robust remediation measures.
The agency warned that failure to address the violations could result in enforcement actions, including withholding approvals for new drug applications and restricting product imports into the United States.
The FDA has requested a detailed response from Granules India within 15 working days, outlining corrective actions and measures to prevent future compliance failures.