USFDA pulls up Granules India for lapses in maintaining storage facilities, equipment at Telangana plant
Granules India for failing to maintain buildings for drug storage and avoiding adequate procedures regarding cleaning and maintenance of equipment at its Telangana-based formulations plant. In a warning letter to the company's Chairman and Managing Director Krishna Prasad Chigurupati, the US Food and Drug Administration (USFDA) stated that the company failed to establish and follow adequate written procedures for maintaining equipment at the Medchal-Malkajgiri-based manufacturing facility.
The USFDA inspected the facility from August 26 to September 6, 2024.
«Our investigators observed significant contamination in multiple ducts of non-dedicated use in the preparation of finished drug products manufactured at your facility,» the USFDA stated.
While filters were installed to prevent contamination, inadequate cleaning and maintenance processes rendered them ineffective, it added.
«Swab samples collected from the ducts by your firm during the inspection, specifically from areas after the high-efficiency particulate air filters, detected residues from multiple previously manufactured drug products and were too numerous to count microbial contamination,» the US health regulator stated.
Artificial Intelligence(AI)
Java Programming with ChatGPT: Learn using Generative AI
By — Metla Sudha Sekhar, IT Specialist and Developer
Artificial Intelligence(AI)
Basics of Generative AI: Unveiling Tomorrows Innovations
By — Metla Sudha Sekhar, IT Specialist and Developer
Artificial Intelligence(AI)
Generative AI for Dynamic Java Web