Granules India Limited hit with 483
Granules India Limited, a drug product manufacturer located in Telangana, India, was found to have several significant violations during an FDA inspection conducted between August 26, 2024, and September 6, 2024.
The FDA’s observations, detailed in Form 483, flagged the company’s cleaning practices, equipment maintenance, and potential product contamination.
One of the major findings was that equipment and utensils used in drug production were not adequately cleaned at appropriate intervals. According to the report, “equipment and utensils are not cleaned at appropriate intervals to prevent that would alter the safety, identity, strength, quality or purity of the drug product.”
Swab sample tests revealed residues of different drug substances above acceptable limits, suggesting a risk of cross-contamination between products: “Test data revealed the presence of different drug substances observed above the acceptance limit indicating a potential risk for drug products cross-contamination.” Additionally, microbial contamination was found, as several swab samples from different areas revealed bacterial and fungal growth inside the Air Purification Units (APUs), jeopardizing the safety of products manufactured at the facility.
The inspection also highlighted inadequate oversight by the company's quality unit, particularly regarding the documentation and control of critical manufacturing records. Torn GMP documents were found among scrap materials, which were improperly discarded. The report states, “The inspection of scrap materials from these trucks revealed presence of large number of torn pieces of GMP documents such as analytical balance printouts, worksheets with handwritten documentation…which were signed and dated.”
Further violations included insufficient cleaning validation for equipment. For example, visible residues of drug substances were found after cleaning processes were reported as completed: “We observed significant quantities of material remaining on the walls…after the cleaning checklist indicated this had already been completed.”
The issues at identified Granules India Limited, and other drug production facilities, serve as a reminder to the pharma industry of the critical need for strict quality control. Lapses like poor cleaning and inadequate oversight can lead to contaminated products, putting patient safety at risk and damaging trust in the supply chain. — Andrea Corona
