The letter, which was sent last month, details a number of GMP deviations observed during an inspection at the plant in Jiangsu province in October 2013.
One of the criticisms the agency made was that Novacyl had failed to document or investigate discrepancies with the finished product, citing as an example the presence of metal particles in an API batch. The US regulator said Novacyl had not determined the root cause of the contamination.
The FDA also raised concerns about the authenticity of data generated by the firm’s laboratory testing: “Our inspection documented multiple instances where the analysts did not record raw material lot numbers during sample preparation, making it impossible to link the raw materials used to the appropriate test worksheet.”
Laboratory failings were also cited as violations in GMP for the active pharmaceutical ingredient (API), also made from the site.
“Our inspection revealed serious deficiencies related to your documentation practices, including missing raw data,” the letter states, high-lighting that an inspector found that a chromatogram for a batch of API, which reported an additional chromatographic peak when compared to the standard, had been thrown away.
“During the inspection, your firm stated that the analyst discarded the chromatogram because it was present in the blank injection. However, the analyst was unable to retrieve the blank chromatogram from the system because it was overwritten by a subsequent injection.”
Other significant failings noted in the letter included Novacyl not having a written procedure for manual integration, not having separate passwords for each analyst’s access to the laboratory systems, and the “presence of many uncontrolled chromatograms, spreadsheets and notes of unknown origin found in a drawer.”
Novacyl was acquired from polymer maker Rhodia in November 2011 by Lyon, France-headquartered firm Novacap.