FDA WARNING_LETTER - Spartan Chemical Company, Inc. - March 26, 2021

The FDA issued a Warning Letter to Spartan Chemical Company, Inc. following an inspection from March 1-26, 2021, identifying significant CGMP violations for finished pharmaceuticals. The company's drug products are deemed adulterated due to non-conformance with CGMP regulations (21 CFR parts 210 and 211) and insanitary conditions, specifically the presence of *Burkholderia cepacia* complex in Lite’n Foamy Lemon Blossom Hand Sanitizer (lot 538756).

Violations include: 1. **Inadequate Production and Process Controls (21 CFR 211.100(a)):** The water system for drug manufacturing was not adequately validated, lacking performance qualification and long-term monitoring. This was a repeat observation from a 2016 inspection. 2. **Insufficient Investigations (21 CFR 211.192):** Investigations into failing results, including microbial contamination with *B. cepacia* and high yeast/mold counts, were inadequate, failing to identify root causes or implement appropriate CAPA. 3. **Quality Control Unit Deficiencies (21 CFR 211.22):** The quality unit failed to provide adequate oversight, leading to contaminated products passing initial release testing but failing later in shelf-life.

Additionally, several products (foamyiQ™ and Lite"n Foamy® hand