FDA WARNING_LETTER - Finemost Corporation - September 21, 2012

On March 20, 2013, the FDA issued a Warning Letter to Finemost Corporation dba Qualiherb following an inspection from September 12-21, 2012. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering their (b)(4) and (b)(4) products adulterated. Additionally, Yi Zhi Tang and C. Aquino’s Happy Pregnancy for Vadevali, Eva Vives products were found to be misbranded under 21 U.S.C. § 343 and 21 CFR Part 101.

Key CGMP violations included: 1. Failure to conduct identity testing for dietary ingredient components prior to use (21 CFR 111.75(a)(1)(i)). 2. Absence of established component specifications for purity, strength, and composition (21 CFR 111.70(b)(2)). 3. Failure to determine if components meet specifications, including inadequate supplier qualification for Certificates of Analysis (21 CFR 111.75(a)(2)). 4. Failure to monitor in-process points to ensure finished batch quality, specifically regarding capsule weight (21 CFR 111.75(b)(1)). 5. Master Manufacturing Records (MMRs) lacking required information