FDA WARNING_LETTER - Ameriderm Laboratories, Ltd. - February 13, 2013

On December 2, 2013, the FDA issued a Warning Letter to Ameriderm Laboratories, Ltd., following an inspection ending February 13, 2013, which identified significant Current Good Manufacturing Practice (CGMP) violations. These violations render the firm's drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to test water for drug manufacturing:** Water used in OTC drug products was not tested for objectionable microorganisms since 2006, with *Pseudomonas aeruginosa*, *Cronobacter sakazakii*, *Burkholderia pseudomallei*, and *Acinetobacter ursingii* found by investigators. The firm's response to increase sampling was deemed inadequate as it did not meet USP Purified Water standards or include a root cause investigation. This was a repeat observation from June 2011. 2. **Inadequate laboratory facilities:** Contract testing laboratory assay methods for finished products (e.g., Instaclean, PeriShield) were not validated. The firm's response failed to address this. 3. **Failure to establish finished product specifications:** No specifications were established for AmeriWash, DermaFix, Instaclean, and PeriShield, and the firm's response lacked scientific rationale or data to support proposed specifications. This was a repeat observation from June