Recsei Laboratories, LLC – FDA Warning Letter, Jul 2, 2013

On January 15, 2014, the FDA issued a Warning Letter to Recsei Laboratories, LLC, following an inspection on July 1-2, 2013, at their Goleta, California facility. The letter identifies significant violations, including the manufacture and distribution of unapproved new drugs and misbranded drugs.

Specifically, prescription drugs such as (b)(4) and (b)(4) are cited as unapproved new drugs under sections 301(d) and 505(a) of the Act, lacking FDA-approved applications. These drugs are also deemed misbranded under section 502(f)(1) due to inadequate directions for use for laypersons.

Additionally, the OTC external analgesic drug product (b)(4) is identified as an unapproved "new drug." Its formulation, combining hydrocortisone and diphenhydramine hydrochloride at specific concentrations, is not recognized as safe and effective under the OTC Drug Review monographs.

The inspection also revealed several Current Good Manufacturing Practice (CGMP) deviations, including: * Failure to establish reliability of component supplier analyses (21 CFR § 211.84(d)(2)). * Failure to reexamine or retest components after long storage or adverse exposure (21 CFR § 211.87). * Failure to establish expiration dates based on adequate stability data (21 CFR §