FDA WARNING_LETTER - BioSan Laboratories, Inc. - January 25, 2011

An FDA inspection of BioSan Laboratories, Inc. (Dec 2010 - Jan 2011) identified significant Current Good Manufacturing Practice (cGMP) violations for dietary supplements, leading to products like Women Over 40 One Daily and Adrenal Response being deemed adulterated (21 U.S.C. 342(g)(1)). Additionally, Megaflora and Adrenal Refresh were found misbranded (21 U.S.C. § 343).

cGMP deficiencies included failure to verify dietary ingredient identity (21 CFR 111.75(a)(1)(i)), releasing finished products not meeting specifications (21 CFR 111.123(b)(2)), and improper management of out-of-specification components (21 CFR 111.77(a)). Master Manufacturing Records lacked corrective action plans (21 CFR 111.210(h)(5)), material review documentation was absent (21 CFR 111.140(b)(3)), and Batch Production Records were incomplete (21 CFR 111.255(b)). Quality control personnel also failed to approve written procedures (21 CFR 111.105(a)).

Misbranding issues for MegaFlora included undeclared Vitamin C (21 CFR 101.36(b)(2)). Adrenal Refresh had incorrect proprietary blend identification (21 CFR 101.36(c)), lacked botanical plant part identification (21 CFR 101.4(h)(1)), and omitted a domestic address/phone for adverse event reporting (21 U.S.C. § 343(y)). The firm also submitted a serious adverse event report late.

BioSan's responses were inadequate, lacking documentation of implemented corrective actions. The FDA requires a written response within 15 working days detailing corrective steps and preventative measures, with supporting documentation. Non-compliance may result in enforcement actions like seizure or injunction.