Granules India Limited — FDA Warning Letter Findings

Your firm failed to routinely calibrate, inspect, or check according to a written program designed to assure proper performance of automatic, mechanical, electronic equipment, or other types of equipment, including computers, used in the manufacture, processing, packing, and holding of a drug product (21 CFR 211.68(a)). You failed to adequately inspect and maintain your AHUs to ensure air filters would be effective at preventing contamination. The procedure for HEPA filter…

Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). Our investigators observed significant contamination in multiple (b)(4) ducts of non-dedicated (b)(4) used in the preparation of (b)(4) for finished drug products manufactured at your facility. While filters were installed to prevent contamination, inadequate cleaning and maintenance processes rendered them ineffective. Swab samples collected…

Your firm failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair (21 CFR 211.58). Bird droppings and feathers were observed during the inspection in the AHU area, specifically on the air purification units, (b)(4) ducts, a (b)(4) tank, a cleaning (b)(4) , and on the floors surrounding multiple (b)(4) inside your drug manufacturing facility. The conditions in your AHU area raise concerns about potential…