US FDA Flags Cleanliness, Maintenance Issues At Cipla’s Goa Plant

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.

The regulator conducted a current good manufacturing practices (cGMP) inspection at Cipla’s Goa unit during 16-27 September and made 12 severe observations, none of which were related to data integrity, the company had said in an exchange filing.

“Cleaning procedures do not include provisions for routine cleaning or inspection of the air inlet/outlet duct areas. During a facility walkthrough, layers of coloured drug products residue were observed on the inside surfaces of air outlet ducts,” the US FDA said in a report, a copy of which has been reviewed by Mint.

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. Shares of the pharmaceutical company dived more than 5% in early trade on Friday. At 1pm, the stock had pared losses and traded 2% higher. – Livemint