U.S. FDA Flags Quality, Procedural Lapses At Torrent Pharma’s Gujarat Facility

The U.S. drug regulator has flagged quality and procedural lapses at Torrent Pharmaceuticals Ltd.'s non-sterile finished product and bulk drug manufacturing facility in Gujarat.

“The U.S. FDA inspected our manufacturing facility at Indrad, Gujarat from Sept. 19-28, 2022. At the end of the inspection, we have been issued a Form 483 with three observations,” the company had said in a Sept. 28 exchange filing.

A Form 483 is issued when investigators have observed any condition that in their judgment may constitute violation of the Food Drug and Cosmetic Act and Related Acts.

None of the observations were related to data integrity, the filing said. “We will respond to the U.S. FDA within stipulated timeline and work closely with U.S. FDA to address the observations at the earliest.”

BQ Prime has obtained a copy of the observations from the FDA.

These are:

1. Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination which could affect the safety, quality of the product: The U.S. FDA pointed out eight specific issues/instances. Residues on already cleaned equipment, swab sample analysis not done properly and may lead to inaccurate cleaning results, inadequate protocols for cleaning validation study of glassware, powder residue and flakes in tanks used for manufacturing, rooms tagged with 'cleaned' status had flooring covered with colour pellets and fine powder traces and powder residues in product contact areas, dent marks on equipment and change in equipment shape which impacted integrity of manufacturing drug products overlooked by quality control unit and used in production and deficient equipment cleaning programs and reports were observed.

2. Failure to review unexplained discrepancy and failure of batch or any components to meet specifications: The U.S. FDA noted that there were frequent invalidations of out-of-specification and laboratory incident investigations without adequately investigating the root cause of manufacturing equipment and laboratory glassware cleaning issues. Twelve laboratory incidents related to unknown and extraneous peaks of which source was not identified were noted. Also, seven instances which might be due to glassware contamination and two out-of-specification investigations were identified. Out-of-specification investigations revealed that the investigation practices are deficient and proposed root causes were not supported by scientific justification.

3. Product quality complaint investigations were deficient: The U.S. FDA noticed that quality unit deviated from procedures and protocols were not adequately followed in regards to the complaint regarding a specific drug product. Also, root cause was not thoroughly investigated and there was a significant delay in issuance of medical assessment report.

Torrent Pharma has yet to respond to BQ Prime's emailed queries on the implications of the observations, revenue contribution from the facility and any potential impact on future approvals and launches. It's also yet to comment on the steps being taken to address these issues and the expected timelines for resolution.