The United States Food and Drug Administration (USFDA) has issued a warning letter to Granules India over lapses in cleaning, maintenance, and record-keeping at its formulations manufacturing plant in Telangana’s Medchal-Malkajgiri district.
The regulatory body inspected the facility between August 26 and September 6, 2024, and found multiple violations of Current Good Manufacturing Practice (CGMP) regulations, which are essential for ensuring drug quality and safety.
Key Observations by USFDA
The USFDA flagged significant contamination issues, particularly in the ducts used for preparing finished drug products. Although filters were installed to prevent contamination, improper cleaning and maintenance rendered them ineffective.
- Contamination in ducts: Swab samples collected from ducts after high-efficiency particulate air (HEPA) filters revealed residues from multiple previously manufactured drug products, along with microbial contamination.
- Poor maintenance of the facility: The inspection found bird droppings and feathers in the air handling unit (AHU) area, including on air purification units, ducts, and floors.
- Data integrity violations: Investigators discovered torn CGMP records in at least 15 plastic waste bags. These included balance printouts and worksheets containing manufacturing and testing data, raising concerns about the integrity of the company’s quality control system.
Consequences and Corrective Measures
In the warning letter addressed to Granules India’s Chairman and Managing Director, Krishna Prasad Chigurupati, the USFDA stated that the company’s drug products were considered adulterated due to non-compliance with CGMP standards.
The regulatory body directed the company to submit a corrective action plan and a timeline for implementing strict oversight measures. These should include:
- Prompt detection of facility contamination issues
- Effective execution of repairs and preventive maintenance
- Timely technological upgrades to facility infrastructure
- Improved management review systems
Additionally, the USFDA may withhold approval of new drug applications or supplements listing Granules India as a manufacturer until the identified deviations are fully corrected. A re-inspection may be conducted to verify compliance.
The company has been given 15 working days to respond in writing, outlining the actions taken to resolve the issues and prevent future violations.
Impact on Granules India
Granules India, a key supplier of pharmaceutical products to the US and global markets, may face regulatory hurdles and potential delays in approvals if the concerns raised by the USFDA are not addressed promptly. Investors and stakeholders will be closely monitoring the company’s response and remedial actions.
Sources By Agencies
