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

Source: https://www.globalkeysolutions.net/records/warning_letter/spartan-chemical-company-inc/00553d39-1c89-4bcf-9918-def187e2d3d5

> FDA WARNING_LETTER for Spartan Chemical Company, Inc. on March 26, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Spartan Chemical Company, Inc.
- Inspection Date: 2021-03-26
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: 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

## Related Officers

- [Associate Director](https://www.globalkeysolutions.net/people/jeffrey-d-meng/55543677-bd74-4cc5-8a2a-e14afb91d338)
- [Eric Mueller](https://www.globalkeysolutions.net/people/eric-mueller/c2da0580-e8b7-41d8-94b6-3579d2bfad8b)

Company: https://www.globalkeysolutions.net/companies/spartan-chemical-company-inc/e8f05d61-ba9a-4ce2-9f3b-3d81600a4897

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0