The FDA has issued Indian CDMO Brassica Pharma a warning letter after inspectors found employees routinely falsified data records.
The regulator inspected Brassica’s facility in the town of Tarapur, located on the west coast of the Indian state of Maharashtra, from Jan. 15 to Jan. 19 and uncovered four manufacturing issues. The warning letter was published Tuesday.
Inspectors found it was “routine practice” for laboratory technicians to make up data for aseptic processing if results had not been collected. While the company told the FDA it would investigate the falsified data, it didn’t include all of the site’s data records and was deemed inadequate by the agency.
Employees were also found to be working with torn, stained and ripped clothing, which can easily lead to contamination. Further, within the facility’s ISO 5 and ISO 7 cleanrooms — used for making sterile drug products — workers were found touching the inside of empty tubes before they were filled.
The agency also said Brassica did not perform sterility testing properly and, during the inspection, four batches made at the site failed sterility tests, including one product for the US market.
The design of the cleanrooms and equipment was also not up to FDA standards and showed “basic deficiencies,” according to the letter. There were also issues in cleaning equipment: For instance, an unmanned piece of equipment made contact with unfilled sterile tubes, which also carries a contamination risk.
The FDA has recommended that the company hire a third-party consultant to help correct the issues outlined in the warning letter and gave Brassica 15 days to cooperate.
Brassica halted the manufacturing and distribution of US drug products from the Tarapur facility on Feb. 22 and recalled current drugs in the US market. The company was also placed on an import alert on Jan. 30. Brassica had replied to the Form 483 on Feb. 8, but the FDA determined its responses were inadequate.
Brassica offers services in manufacturing liquid oral, sterile semi-solid drug products and dermatologicals.