BENEV Company Inc – FDA Warning Letter

The FDA issued a Warning Letter to BENEV Company, Inc. following inspections in September 2009 and February 2010, citing significant Current Good Manufacturing Practice (CGMP) violations for Finished Pharmaceuticals, rendering their drug products adulterated. The firm's responses were inadequate, with several CGMP issues being repeat violations. Key CGMP deficiencies included inadequate investigations (21 CFR § 211.192), poor complaint handling (21 CFR § 211.198), failure to reject non-conforming components (21 CFR § 211.84(e)), unvalidated processes and inadequate production controls (21 CFR § 211.100(a)), deficient batch records (21 CFR § 211.188), insufficient stability testing (21 CFR § 211.166(a)), lack of component identity testing (21 CFR § 211.84(d)(2)), and inadequate cleaning procedures (21 CFR § 211.67(b)) and personnel training (21 CFR § 211.25(a)). Additionally, BENEV was found manufacturing and marketing unapproved new prescription and OTC drugs without FDA approval, violating sections 301(d) and 505(a) of the Act. These products were also misbranded due to lacking adequate directions (502(f)(1)), non-compliance with OTC monographs, absence of "Drug Facts" panels (502(c), 21 CFR § 201.66), and failure to be listed (502(o), 510(j)) or manufactured in a registered establishment (502(o), 510). The FDA demands prompt corrective actions within fifteen working days, including discontinuing unapproved drug marketing and updating drug listing files. All corrective actions must be fully implemented before resuming manufacturing. A third-party CGMP consultant was recommended. Non-compliance could result in legal action and impact business operations.