Beanne Chemical Co. – FDA Warning Letter, May 4, 2012

On December 19, 2012, the FDA issued a Warning Letter to Beanne Chemical Co. following a May 2-4, 2012 inspection of their pharmaceutical manufacturing facility in Taiwan. The inspection revealed significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering their drug products adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. Additionally, the firm failed to fulfill drug registration and listing obligations under Sections 510(i)(1), 510(i)(2), and 510(j) of the Act, a prohibited act under Section 301(p).

Key violations include: 1. **Lack of Process Validation (21 CFR 211.100(a)):** The firm failed to validate manufacturing processes for several drug products, including (b)(4) Cream, (b)(4) Medication, and (b)(4) Cream, and admitted no process validation, cleaning validation, or equipment qualification had been conducted. 2. **Inadequate In-Process Controls (21 CFR 211.110(a)):** The firm did not perform adequate in-process testing for the aforementioned products, with management stating no procedure for sampling and testing in-process materials existed.