FDA WARNING_LETTER - Chemical Services Group, Inc./Royal Chemical Company - November 08, 2022

On April 5, 2023, the FDA issued a Warning Letter to Royal Chemical Company following an inspection from October 31 to November 8, 2022, at their East Stroudsburg, PA facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The company's November 22, 2022, response to the FDA 483 was deemed inadequate.

Violations included: 1. **Failure to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b))**: OTC hand sanitizer drug products were manufactured on equipment also used for industrial chemicals, posing a cross-contamination risk. Procedures for cleaning transfer pipes and external storage tanks were also lacking. 2. **Failure to validate and establish the reliability of component supplier’s test analyses (21 CFR 211.84(d)(2))**: The firm relied on unqualified supplier Certificates of Analysis for ethanol, failing to ensure incoming components met specifications. Inadequate supplier identification, co-mingling of ethanol lots, and poor batch traceability were also noted. 3. **Failure to establish adequate acceptance criteria for sampling and testing (21 CFR 211.165