- The FDA has warned a German API manufacturer over manufacturing violations discovered in a May 2015 inspection, according to a letter posted to the regulators website this week.
- According to the letter, BBT Biotech failed to follow its own procedures for stability testing, leading it to ship APIs to the U.S. without any stability data to support expiration dates. BBT also didn’t adequately investigate out-of-specification results.
- Both the FDA and the European Medicines Agency (EMA) have increased their oversight and inspection of biopharma manufacturing facilities worldwide. The increased scrutiny has led to more warnings, particularly in production centers like India and China.
As is typical in many of these warning letters, the FDA also censured BBT for its lack of access controls and audit trail capabilities. All employees at BBT’s Baesweiler facility shared a single user name and had administrator privileges, for example. This opened up the company to the risk of employees accidentally or purposefully deleting or changing data critical to determining ingredient safety.
The FDA has warned BBT it could be banned from exporting API materials if it doesn’t address these issues in a timely manner.
Regulatory challenges at plants in India and China have occurred much more frequently. Just two weeks ago, the FDA warned a Chinese API manufacturer in Shanghai. And last week, the EMA announced disciplinary action against two Indian plants for cGMP violations, reports FiercePharma.
The US is not immune to quality-control issues at its manufacturing facilities either. A little more than a week ago, the Swedish Medical Products Agency (MPA) said it would withdraw the E.U. GMP certificate from a subsidiary of the major CRO Capsugel after finding two critical and seven major deficiencies at its Bend, Oregon site.
The predominance of Indian and Chinese firms among manufacturers cited by the FDA reflects concerns from both lawmakers and the regulator over the safety and accountability of exports from those two countries. Combined, Indian and China supply most of the world’s APIs, including in the U.S.