Frontida warned by FDA over GMP violations
- Frontida BioPharm, an affiliate of a Chinese-owned CDMO, has received a firmly-worded warning from U.S. drug regulators following a month-long inspection of its Philadelphia manufacturing facility.
- Violations noted by inspectors from the Food and Drug Administration included improper release of 27 batches of potentially-contaminated drugs.
- Frontida bought the plant from the Indian giant Sun Pharma two months ago, taking over solid dosage manufacturing of 15 pharmaceutical products. Frontida also agreed to continue producing "certain products" of Sun Pharma on a contract basis.
After a month of inspections at Frontida’s drug manufacturing facility in Philadelphia, PA, the regulatory authority issued a warning letter on 15 August 2016. This letter, based on an inspection in June and July 2015, flagged several quality control violations, including the knowing release of potentially contaminated drugs.
In March 2015, the plant, then under the auspices of Sun Pharma, released 27 lots of clonadine HCI tablets, a drug used to treat a range of conditions including high blood pressure. This was done despite knowledge the active pharmaceutical ingredient in the tables could have been contaminated.
The plant's supplier had recalled that lot of API after an inspection had discovered insufficient controls to prevent cross-contamination.
Other failings included inadequate investigation of stability failure of felodipine tablets, another antihypertensive, discrepancies in cGMP recordkeeping and failure to allow the inspectors full access to information.
The warning letter notes, for example, that a vice president of quality "repeatedly denied" knowing of the clonidine recall despite e-mail evidence which showed the individual had been notified in 2014.
The plant is a former Mutual Pharmaceutical Company facility that Frontida bought from Sun Pharma in June 2016, along with another in Aurora, IL. Frontida is an affiliate company to Frontage Laboratories, which is in turned owned by the Chinese CRO Hangzhou Tigermed.
- FDA Warning letter
- Regulatory Focus FDA Warns Pennsylvania Drugmaker Over GMP Violations
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