India’s Jubilant Generics and Contract Pharmaceuticals Limited Canada were each hit with Form 483s by the FDA following inspections that uncovered questionable manufacturing practices.
The Jubilant Generics inspection, which took place at the company’s production facility in Bhagwanpur, India, between Jan. 25 and Feb. 2 earlier this year, cited four observations, according to a letter posted April 5 on the U.S. regulatory agency’s website.
Inspectors found the facility failed to investigate and identify the root cause of the presence of out-of-specification drugs in a batch of unspecified drugs that were later distributed in the U.S. after they were found in swab samples taken during a cleaning verification process, the FDA said.
Additionally, the site’s quality control unit was cited for not keeping proper records or following written procedures after an inspector “observed the presence of at least three uncontrolled investigation documents in a locked bin that were placed for shredding.”
The two other observations found the facility didn’t establish appropriate time limits for the completion of each production phase and failed to put control procedures in place that would validate the manufacturing processes.
Separately, the agency issued a Form 483 to Contract Pharmaceuticals Limited in the wake of an inspection between Oct. 30 and Nov. 3, 2023, of its Mississauga facility located near Toronto. The FDA cited one observation.
The company failed to “thoroughly review any unexplained discrepancy whether or not (a specific) batch has been already distributed.,” the agency said in a letter posted to its website April 3.
A third-party contract lab found brucella melitensis, a highly pathogenic microorganism, during an environmental monitoring of the production area. When notified of its presence, however, the company didn’t initiate an incident report in order to conduct a documented investigation of the finding, the agency said.