Uriel Pharmacy, Inc – FDA Warning Letter, Nov 1, 2010

The FDA issued a Warning Letter to Uriel Pharmacy, Inc. following an inspection from October 18 to November 1, 2010, which revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211). These violations render their drug products adulterated under 21 U.S.C. § 351(a)(2)(B). Additionally, the FDA found several drug products, including "Arnica Rosa" and "Arnica Plumbum Mel," to be misbranded under 21 U.S.C. §§ 352 and 331, based on labeling and website review.

Key CGMP violations include: 1. **Lack of sterile product procedures (21 CFR 211.113(b)):** Failure to validate sterilization cycles, document parameters, use Water for Injection (WFI) for sterile products, and validate sterilizing filters. The firm used a filter labeled for laboratory use. 2. **Inadequate container/closure sterilization (21 CFR 211.94(c)):** Failure to validate depyrogenation processes for glassware used in sterile injectables. 3. **Insufficient process control procedures (21 CFR 211.110(a)):** Inadequate controls for ampule filling/closing, leading to glass particulates and a