FDA WARNING_LETTER - Vilvet Pharmaceutical - June 27, 2018

The FDA inspected Vilvet Pharmaceuticals, Inc. from June 18-27, 2018, identifying significant current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering drug products adulterated under 21 U.S.C. 351(a)(2)(B). Additionally, the firm commercially distributes unlisted drugs ((b)(4) and (b)(4)), violating 21 U.S.C. 360(j) and 331(p), and rendering them misbranded under 21 U.S.C. 352(o). Key CGMP deficiencies include failure to establish an adequate quality control unit and procedures (21 CFR 211.22(a) and (d)), particularly regarding batch review and disposition for contract-manufactured products. The firm also lacked and had inadequate written procedures for critical quality control functions. The FDA emphasized the firm's ultimate responsibility for drug quality, regardless of contract agreements. Furthermore, the warning letter cited multiple dietary supplement labeling violations for VIL-DHA Capsules and VIL-Rx Tablets, including failures to comply with nutrition labeling requirements (21 CFR 101.36), lack of a statement of identity (21 CFR 101.3(g)), failure to declare common ingredient names (21 CFR 101.4(a)(1)), and missing manufacturer's address details (21 CFR 101.5(d)). The FDA recommends engaging a qualified CGMP consultant and requires a written response within 15 working days detailing corrective actions, retrospective reviews, risk assessments, and plans for establishing a robust internal quality unit. Failure to correct violations may lead to legal action, including seizure, injunction, and impact on drug approvals and export certificates.