FDA WARNING_LETTER - Anhui Hanbon Daily Chemical Co., Ltd. - February 28, 2025

Anhui Hanbon Daily Chemical Co., Ltd., located at No. 55 Chuangye Avenue, Xinqiao International Industrial Park, Huainan, Anhui, China, was inspected by the FDA from February 24 to 28, 2025. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, as outlined in Title 21 CFR parts 210 and 211. Consequently, the company"s drug products are considered adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key violations include:

1. **Inadequate Component Testing**: The firm failed to conduct proper identity testing on incoming component lots, including active ingredients, relying instead on inadequate tests such as appearance and microbiological attributes. This oversight led to the use of incorrect excipients and potentially contaminated ingredients.

2. **Unvalidated Test Methods**: The company did not validate the accuracy, sensitivity, specificity, and reproducibility of its test methods. It released drug batches without adequate testing, failing to demonstrate that in-house methods were equivalent or superior to USP standards.

3. **Lack of Stability Testing**: The firm did not establish a proper stability testing program, lacking data from long-term or accelerated conditions to ensure product quality throughout the labeled expiry period.

4. **Inadequate Process Validation**: The company failed to validate its manufacturing processes, lacking assurance of consistent product quality. There was no process qualification or data to support manufacturing parameters.

The FDA requires Anhui Hanbon to provide detailed corrective actions, including validation of test methods, establishment of a comprehensive stability program, and completion of process validation studies. The FDA also recommends consulting a CGMP expert to address these compliance issues effectively.