FDA hits Lupin’s New Jersey site with warning letter

July 5, 2021

The FDA recently issued a warning letter to Lupin, one of the world’s largest generic drugmakers, for a number of quality-related failures.

Although it’s based in India, the FDA warning letter was sent to the company’s Novel Laboratories factory in New Jersey. 

In the letter, dated June 11 but recently posted by the agency, the FDA said the violations were observed during an inspection late last year, which then prompted a Form 483.

Now, in the follow-up warning letter, the agency dinged Lupin for inadequate cleaning  procedures of equipment, and in particular, its tablet press. According to the agency, FDA inspectors spotted residue on a tablet press and although Lupin later analyzed the residue, the company failed to test reserve samples of drug products manufactured on the equipment.

“There is no assurance that you can prevent cross-contamination because your corrective action and preventive action (CAPA) plan fails to include cleaning the (b)(4) duct at drug product changeover,” the agency said.

The FDA also cited the company for producing and releasing temazepam in two different dosages using a manufacturing process that wasn’t adequately validated when production was moved to a new building.

In its conclusion, the FDA chided Lupin for repeated cGMP violations and pointed to warning letters issued to the company in 2017 and 2019.

The agency threatened to withhold the company’s Export Certificates and approval for new applications if Lupin fails to address the violations.