Laclede Inc – FDA Warning Letter, Jun 27, 2012

On February 14, 2013, the FDA issued a Warning Letter to Laclede, Inc. following a June 19-27, 2012 inspection. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, causing their drug products to be adulterated under 21 U.S.C. § 351(a)(2)(B). Additionally, the firm was found to be manufacturing and marketing unapproved and misbranded drug products, including the OTC Luvena Prebiotic Vaginal Moisturizer & Lubricant and two topical fluoride prescription drugs, violating 21 U.S.C. §§ 331(a), (d), 355(a), 352(c), and 352(e)(1)(A)(ii) and (iii).

Specific CGMP violations included: 1. Failure to conduct appropriate laboratory determination of satisfactory conformance to final specifications for drug products, including identity and strength of active ingredients, prior to release (21 CFR § 211.165(a)). Laclede did not test active ingredients like lactoferrin in Luvena Prebiotic, despite FDA's designation of these as active. 2. Failure to establish and follow an adequate written stability testing program (21 CFR § 211.166(a)). The firm lacked stability-indicating test methods