FDA Warns Apotex’s India Facility on cGMP Violations

The FDA slapped Canadian generics maker Apotex with a warning letter for serious lapses in current good manufacturing practices at its Bangalore, India, finished product plant.

According to the Jan. 30 letter, Apotex failed to adequately record test results and microbiological test plates were missing for various finished drug products. The plant’s quality unit also failed to review and approve production and control records didn’t take adequate security measures to ensure only qualified personnel made changes to master production and control records, the letter says.

This continues a string of data integrity violations for international manufacturers. The FDA cited data integrity violations in 13 warning letters out of the 18 issued for good manufacturing practice violations in 2014.

Apotex had expected the warning letter, says spokesman Steve Giuli. The FDA placed an import ban on products made at the Bangalore plant last fall after investigators cited the cGMP issues during a June 23 to July 1, 2014, inspection. Health Canada also banned imports from that plant and a separate raw materials facility nearby.

Since the inspection, Apotex has implemented training programs and new procedures to reduce employee error, Giuli said. The improvements are being validated by third-parties.

The warning letter asks Apotex to provide the FDA with a comprehensive evaluation of the plant’s test results, an assessment of potential risks associated with the quality failures and a management strategy with a detailed CAPA plan.

Don’t get hit with a warning letter because of cGMP violations. Complying with 21 CFR Part 211 regulations is complex and detailed for a new employee, so train them the right way with cGMP Basics.