After 'misleading' information delays FDA inspection, Chinese API manufacturer hit with an OAI
Chinese API manufacturer Sichuan Deebio Pharmaceutical received an “official action indicated” classification following a September Form 483 detailing quality control and batch discrepancy issues.
The facility was flagged by the FDA for poor record keeping too, with a team leader telling inspectors that some data results were kept “in her mind.”
The agency noted six significant observations during its inspections between Sept. 4 and Sept. 8, 2023 at the site in Xiaolan Town, Sichuan, in southeast China. In the Form 483 dated Sept. 8, details of the drug substances affected by these issues were redacted.
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