FDA cites Chinese manufacturers for GMP lapses
- The Food and Drug Administration has banned drug imports from Chinese API manufacturer Hebei Yuxing Bio-Engineering, citing widespread failures in the firm's quality control processes, rejecting the firm's initial responses to a August 2015 inspection as "inadequate."
- Hebei Yuxing improperly deleted chromatographic data and routinely conducted purportedly experimental tests of product batches without recording their results, according to the FDA warning letter. FDA inspectors also noted "persistent and unresolved" instances of microbiological contamination at the company's Hebei plant.
- Fifty-four Chinese firms have been placed on the FDA's import ban list, and the regulator's stepped-up oversight of Chinese pharmaceutical sector has led to a spate of new warning letters this year.
In an inspection last year, FDA inspectors found evidence of poor quality control practices, including deleted raw data files related to API batch samples being tested. Hebei Yuxing's quality control unit also appeared to routinely conduct undocumented experimental tests of product out of "fear" that the drugs wouldn't pass quality testing.
The company told the FDA it had acquired new chromatographic instruments and installed new systems in response. That failed to placate the FDA though, which indicated the firm's response did not explain why records weren't maintained properly.
When the FDA inspected Hebei Yuxing's plant in August 2015, the manufacturer had documented 67 cases of microbiological contamination. In the FDA's opinion, however, the contamination was part of a continuing problem which dated back to 2013.
As a result, the FDA placed Hebei Yuxing on its import alert list on July 8, 2016 and is requiring the firm conduct a comprehensive investigation into its data reporting, a risk assessment and a detailed corrective/preventative action plan.
Another Chinese API supplier, Cheng Fong Chemical, was also cited in another recently released warning letter from the FDA but was not placed on import ban.The letters to Hebei Yuxing and Cheng Fong are the 11th and 12th such warnings sent by the FDA's Office of Manufacturing Quality this year, part of a stepped-up effort to police the Chinese pharmaceutical sector.
- FDA Warning Letter
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