Current Edition

Antibiotics pro Centrient runs afoul of FDA at Indian manufacturing plant

The FDA’s cadre of Indian manufacturing investigators has dished up yet another warning letter. This time, the dishonor goes to the local branch of Dutch antibiotics specialist Centrient Pharmaceuticals.

Following an inspection from late June to July 1, the FDA wrote up Centrient’s manufacturing facility in the Indian state of Punjab for lapses in its drug ingredients production processes. The formal manufacturing citation comes despite a prior wrist slap from the U.S. regulator in the shape of a Form 483 filing.

The FDA took issue with Centrient’s production operations on three counts.

First, the agency chided Centrient for the failure of its quality unit to make sure the company’s active pharmaceutical ingredients (APIs) were up to par. Centrient’s quality control unit dropped the ball when it came to document control over paper and electronic records plus management of its computer systems, the FDA said.

Investigators said they uncovered “numerous” partially completed logbooks in a temporary storage room near Centrient’s microbiology lab. Further, FDA officials took notice of a document shredder at the site labeled “emergency use” that contained shredded documents.

“Your document control personnel were unable to identify the documents in the shredder that were observed to contain information for relative humidity, temperature, and data recorded in writing,” the investigators wrote in their letter.

As for Centrient’s subpar computer controls, “multiple” usernames and passwords for software login were “handwritten in an uncontrolled notebook of your senior executive microbiologist.”

The FDA hinted that Centrient’s top microbiologist might have been inputting data in his co-worker’s stead.

“To ensure data integrity, actions performed need to be attributable to a specific individual,” the regulator noted.

Centrient’s second manufacturing offense centered on faulty testing needed to confirm its APIs met quality and purity standards. Specifically, the company failed to ensure its testing procedures were “appropriately validated” and that “established procedures were followed,” the FDA said.

Last, but not least, Centrient was dinged for failing to establish and follow written procedures to investigate “critical” API batch deviations or failures. In particular, Centrient failed to investigate and suss out the cause of “black particles” that turned up in two batches of an unnamed drug ingredient.

Given the nature of Centrient’s production blunders, the FDA has recommended the company hire a manufacturing consultant to help right the ship.

Beyond Centrient’s Indian branch, U.S. FDA investigators have taken a hard line with manufacturers on the subcontinent in recent months.

Just last week, for instance, the FDA issued an import alert to one of Sun Pharma’s manufacturing facilities in the Indian state of Gujarat.

Earlier in December, generics giant Glenmark Pharmaceuticals’ plant in Goa, India, was slapped with a warning letter from the FDA outlining a laundry list of problems tied to batch failures, lab controls, record-keeping and more.

And, in October, manufacturing giant Lupin said on the Bombay Stock Exchange that it had received a Form 483 from the FDA linked to problems at an injectables plant in Nagpur. The announcement marked the third time in the span of five weeks that Lupin revealed a compliance reprimand from the FDA in a regulatory filing.