USFDA Warns Granules India Over Facility Violations

The USFDA has criticized Granules India for inadequate maintenance and cleaning procedures at its Telangana plant, leading to contamination issues. A warning letter outlines significant CGMP violations and demands corrective actions. The USFDA may withhold drug application approvals until compliance is achieved.

In a stern warning, the US Food and Drug Administration (USFDA) has issued a letter to Granules India, highlighting serious lapses at its formulations manufacturing plant in Telangana. The notice criticizes the company for failing to maintain its buildings, crucial for drug storage, and for neglecting essential cleaning and maintenance procedures for equipment.

Inspections carried out by the USFDA between August 26 and September 6, 2024, revealed alarming contamination in ducts used for drug preparation. Despite the installation of filters, improper cleaning and maintenance rendered them ineffective, leading to widespread contamination concerns that were backed by swab samples showing microbial and residue contamination.

The US health regulator has demanded an immediate plan to address these issues, including a proposal for stringent operational oversight, efficient detection and repair systems, and adherence to preventive maintenance. The USFDA has warned that Granules India's drug applications may face approval delays until compliance with CGMP standards is confirmed.

(With inputs from agencies.)