HYDERABAD: The US Food and Drugs Administration (USFDA) made 12 observations including those related to hygiene and maintenance of equipment and utensils at Indian pharmaceutical firm Cipla’s manufacturing facility in Goa.
The move prompted Cipla shares to tank to a 52-week low of Rs 389.55 in early trade on BSE Friday, but given that there were no data integrity issues, the scrip recovered fairly well to close at Rs 441.55.
According to the inspection report, Cipla failed to clean, maintain and sanitise 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. During a facility walk through, layers of coloured drug products residue were observed on the inside surfaces of air outlet ducts,” the USFDA said in its report.
The inspection was conducted across 10 units of the Goa facility that produces varied dosage forms for over 10 days from September 16-27. The FDA observed that the facility didn’t provide equipment for adequate control of air pressure, micro organisms and dust, necessary while manufacturing, processing, packing or holding of drugs.
“We expect there will be limited financial impact (sales of $40-50 million) due to lack of new approvals from the facility. We note that most of the new filings are from the Indore facility. Also, company can do site transfers for large products (Cipla has multiple FDA approved plants),” said Krishnanath Munde, senior analyst, Reliance Securities.
The regulator conducted cGMP (current Good Manufacturing Practice) inspection at its Goa unit during September 16-27 and made 12 severe observations, none of which were related to data integrity, the company said.