Granules India Receives USFDA Warning Over Manufacturing Lapses

Granules India has received a USFDA warning for inadequate cleaning and maintenance at its Telangana plant. Contamination risks, improper equipment procedures, and discarded CGMP records were cited. The company must submit a corrective action plan within 15 days or risk further regulatory consequences, including withholding drug approvals.

The US Food and Drug Administration (USFDA) has issued a warning to Granules India regarding significant lapses in cleaning, maintenance, and compliance at its Telangana-based manufacturing facility. Following an inspection conducted between August 26 and September 6, 2024, the US regulator identified contamination risks, improper cleaning procedures, and infrastructure-related deficiencies at the Medchal-Malkajgiri plant.

According to the USFDA’s warning letter addressed to the company's Chairman and Managing Director Krishna Prasad Chigurupati, the facility failed to establish adequate procedures to maintain its equipment properly. Inspectors found microbial contamination and residues from multiple previously manufactured drugs in the ducts after the high-efficiency particulate air filters. Additionally, bird droppings and feathers were observed in the air handling unit (AHU) area, further raising concerns about contamination risks.

The inspection also uncovered that a substantial number of torn Current Good Manufacturing Practice (CGMP) records, including manufacturing and testing data, were discarded in plastic waste bags. The USFDA criticized the company’s quality control system, stating it does not ensure the accuracy and integrity of data, ultimately affecting the safety and effectiveness of the drugs produced.

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The regulatory body has warned that unless the company addresses these violations, the USFDA may withhold approval of new drug applications listing Granules India as a manufacturer. The company must submit a detailed corrective action plan within 15 working days, including steps to prevent contamination, enhance facility maintenance, and improve data integrity. Failure to comply may lead to further regulatory action, including possible re-inspection to verify corrections.