FDA WARNING_LETTER - Sunstar Americas, Inc. - February 18, 2021

The FDA inspected Sunstar Americas, Inc.'s Schaumburg, Illinois facility from January 12 to February 18, 2021, identifying significant violations of Current Good Manufacturing Practice (CGMP) for pharmaceuticals and Quality System (QS) regulations for medical devices. This renders their drug products adulterated under 21 U.S.C. 351(a)(2)(B) and devices, including G•U•M® HYDRAL™ OTC products, adulterated under 21 U.S.C. § 351(h).

Key violations include: 1. **Inadequate Production and Process Control Procedures (21 CFR 211.100(a) and (b)):** Deficiencies in water system validation, including undocumented excursions, lack of scientific data for sanitization frequency, and reduced sampling despite high microbial counts. The firm must provide an independent assessment, a remediation plan for the water system, and ensure appropriate microbial limits. 2. **Failure to Investigate Discrepancies (21 CFR 211.192):** Numerous uninvestigated microbiological contaminations (e.g., *Burkholderia contaminans*) and deviations in water system operation. A CAPA for *Burkholderia cepacia* was closed without corrective action. The firm must conduct a retrospective review of all OOS/OOT results and deviations,