The US Food and Drug Administration has made critical observations related to hygiene and maintenance of equipment and utensils at Cipla Ltd’s manufacturing facility in Goa. The regulator said the drugmaker failed to clean, maintain and sanitize utensils and equipment at appropriate intervals, raising the risk of contamination and compromising the safety and quality of the products. “Cleaning procedures do not include provisions for routine cleaning or inspection of the air inlet/outlet duct areas. The regulator also observed that the manufacturing facility did not provide equipment for adequate control of air pressure, micro-organisms and dust --necessary while manufacturing, processing, packing or holding of drugs. The report led to a fall in Cipla’s shares as investors feared action against the manufacturing facility by the US FDA.
Source: Mint October 11, 2019 08:48 UTC