FDA EIR - Henan Dongtai Pharm Co., Ltd. - August 11, 2023

The FDA conducted a surveillance inspection of Henan Dongtai Pharm Co., Ltd. from August 7 to August 11, 2023. This assessment focused on the company's manufacturing of drug intermediates and active pharmaceutical ingredients (APIs) under relevant compliance programs for drug intermediate and API processes. Unlike a previous 2018 inspection, which resulted in a corrected minor observation, the recent evaluation concluded with a "No Action Indicated" (NAI) classification, meaning no formal violations were found, and no FDA Form 483 was issued.

However, several minor operational and procedural points were discussed verbally with the firm. These included the absence of a specified timeframe in the out-of-specification (OOS) procedure for reporting failures and initiating investigations, a lack of established procedures for power failures, and missing identification or status indicators for a portable device. Concerns also arose regarding validation documentation not fully demonstrating process robustness and the grouping of similar equipment for maintenance sign-offs. Notably, the firm promptly addressed the first three verbal discussion items during the inspection.

Based on these findings, the FDA inspector will recommend site approval for the manufacturing of the drug intermediate, with no further regulatory actions required from the company.