US FDA raises concerns on Cipla's Indore plant

Firm says it is working with regulator to ensure highest quality

Drugs administration has made adverse observations regarding manufacturing practices at drug maker Cipla's Indore plant.

The observations commonly referred to as Form 483 were issued following the US agency's inspection in July.

While Cipla did not specifically comment on FDA observations and said it is working closely with regulators to ensure highest quality standards,  the inspection did raise concerns about quality control measures initiated by the company.

The US FDA investigators observed that quality control units lacks the authority to review production records to ensure no errors have occurred. They said the procedures designed to prevent microbiological contamination of drug products do not include adequate validation of sterilization process.. The inspection also found deficiencies regarding aseptic processing of drug products and  also observed that sterile product vials exiting the filling line were handled by ungloved and unsanitized hands by packaging line employees before they were packed into cartons.

“Cipla works closely with the regulatory authorities to ensure that we maintain the highest quality standards.  As a policy we never comment publically on these interactions,” a company spokesperson said in an email response.

Other top pharma companies including Sun Pharmaceuticals and Wockhardt have been under the FDA scanner leading to product recalls and import alerts.

The  483 observations however are bad news for Cipla as it looks to expand in the US market. US market contributes 8 percent to its revenue and the company plans to step up its presence increasing sales of its front end labels and recent $ 550 million acquisition of InvaGen Pharmaceuticals and Exelan Pharmaceuticals.

Cipla stock fell 2.13 percent to close at Rs 672.45 on Tuesday.