FDA slams 3 Indian drugmakers in flurry of recent Form 483s

The FDA slammed three Indian drugmakers with Form 483s following recent inspections that uncovered unsanitary conditions, broken equipment and poor recordkeeping.

Mumbai-based Alkem Labs was cited with 10 observations in the wake of a March inspection of its facility in Baddi, India. Under the first observation, inspectors said the company didn’t review unexplained discrepancies and the failure of a batch or of its components nor investigate whether the batch had been distributed to customers.

Specifically, Alkem's quality control unit didn’t take appropriate steps after a “glove like” material was found inside a sealed bottle of unspecified tablets, the FDA said. The agency's inspector said that following the discovery of a foreign object by a pharmacist, the company “did not take effective measures to prevent recurrences.”

Alkem was also cited for not maintaining areas of manufacturing, processing and packing in a good state of repair. The inspection found there was no hot water for production workers to wash their hands, and there was a cracked ceiling, peeling paint and a “leakage stain” in a production area for drugs bound for the U.S.

Other observations included failing to clean and sanitize equipment and utensils, improper keeping of computer records, unsatisfactory handling of drug product containers and lax laboratory controls.

Cipla Limited, also based in Mumbai, was hit with six observations following an inspection by the U.S. regulatory agency from March 28 through April 4 at its Patalganga facility located in Raigad, India.

During the inspection, a large gap in a duct seal was found near the area where an API was produced for distribution in the U.S.

“We were able to insert a folded 8x11-inch piece of paper into the duct seal gap and confirmed that the duct seal was non-integral and breached,” the FDA inspector said in the Form 483 document. “Your firm was unaware of the breach, the cause, and the duration for which the breach has been present.”

The facility was also cited for failing to clean and maintain equipment at appropriate intervals, not adequately investigating out-of-specification results and failure to follow procedures at the quality control unit.

Zydus Lifesciences, formerly known as Cadila Healthcare, was issued a Form 483 after its facility in Matoda, India, was inspected between March 18 and March 27.

The inspection resulted in four observations that mainly involved a lack of proper maintenance of facilities, failing to clean and maintain equipment that could impact the strength, quality and purity of the drug produced at the site, and lacking procedures to prevent microbiological contamination of sterile products.

The FDA posted the Form 483 documents on its website last week.