Another domestic pharmaceutical company receives FDA warning, This time targeting Sitagliptin raw material manufacturer. The company: Issues with documentation process, related to product quality.

Following the FDA warning letter received by Huahai Pharmaceutical in June this year, another domestic pharmaceutical company recently received a warning from the FDA regarding their sitagliptin raw material. The warning letter outlined deviations in the current Good Manufacturing Practices of a domestic company in raw material production. This included the company failing to conduct process validation on the production of sitagliptin, a glucagon-like peptide-1 receptor agonist raw material, and not testing the results of each batch of incoming production material identification. On September 26, the company told reporters that this is actually a common phenomenon in the industry, and that FDA warning letters are usually issued based on on-site inspections or findings during document audits, as reminders or warnings to companies. "For us, the FDA warning this time is mainly based on issues found in the document process, unrelated to the company's own production process and product quality."