FDA WARNING_LETTER - NuSil Technology LLC - May 04, 2011

On March 22, 2012, the FDA issued a Warning Letter to NuSil Technology LLC, following an inspection from April 18 to May 4, 2011, at their Bakersfield, CA facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations for Active Pharmaceutical Ingredient (API) manufacturing, rendering their APIs adulterated under 21 U.S.C. § 351(a)(2)(B). The firm's May 18, 2011, response was deemed insufficient.

Key violations included: 1. **Inadequate Out-of-Specification (OOS) Procedure:** The firm released Simethicone Emulsion USP (30%) lot (b)(4) based on retests after an initial microbial result of >11,000 CFU/g, without justifying the invalidation of original results or identifying a root cause. The OOS procedure (SOP# (b)(4)) lacked requirements for data analysis, problem assessment, root cause identification, or corrective action allocation. The firm's proposed SOP modification was inadequate as it lacked scientific justification and documentation for retesting and proper investigation. 2. **Failure to Adequately Clean and Store Equipment:** The firm did not routinely clean equipment after each manufacturing run. Their cleaning procedure allowed a (b)(4) "dirty hold time" without supporting validation data. Microbial contamination of