The US Food and Drug Administration (USFDA) has issued a stern warning letter to Granules India, highlighting serious violations at the company's formulations manufacturing facility in Telangana, India. The regulatory action follows an extensive inspection conducted between August 26 and September 6, 2024, which revealed multiple critical lapses in manufacturing practices and facility maintenance.
Critical Contamination and Maintenance Issues
FDA inspectors documented "significant contamination" in multiple non-dedicated ducts used in the preparation of finished drug products. Despite the installation of high-efficiency particulate air (HEPA) filters, inadequate cleaning and maintenance procedures rendered these protective measures ineffective.
Swab samples collected from areas beyond the HEPA filters detected residues from multiple previously manufactured drug products and showed microbial contamination levels that were "too numerous to count," according to the regulatory agency's findings.
The warning letter, addressed to Chairman and Managing Director Krishna Prasad Chigurupati, specifically cited the company for failing to maintain buildings used in drug manufacturing in a good state of repair. Inspectors observed bird droppings and feathers in the air handling unit (AHU) area, including on air purification units, ducts, and floors inside the drug manufacturing facility.
Documentation and Quality System Failures
In a particularly concerning discovery, FDA investigators found "a large amount of torn CGMP records" in at least 15 plastic waste bags during the inspection. These discarded documents included analytical balance printouts and worksheets containing critical manufacturing and testing data.
"Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture," the USFDA stated in its communication to the company.
Regulatory Implications and Required Actions
The FDA has classified these violations as significant breaches of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. As a result, the agency has determined that drug products manufactured at the facility are considered "adulterated" under federal regulations.
The warning carries significant business implications for Granules India. The FDA explicitly stated that it "may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP."
Required Remediation Plan
The regulatory agency has demanded that Granules India respond within 15 working days with a comprehensive plan to address the violations. The company must implement:
- Routine, vigilant operations management oversight of facilities
- Systems for prompt detection of facility contamination issues
- Effective execution of repairs
- Adherence to appropriate preventive maintenance schedules
- Timely technological upgrades to facility infrastructure
- Improved systems for ongoing management review
The FDA also indicated it may conduct a re-inspection to verify the completion and effectiveness of corrective actions before considering the facility compliant with regulatory standards.
This regulatory action represents a significant challenge for Granules India, potentially affecting its ability to supply pharmaceutical products to the US market until the issues are fully resolved and compliance is restored.
