FDA WARNING_LETTER - Uriel Pharmacy, Inc - March 04, 2025

The FDA issued a Warning Letter to Uriel Pharmacy, Inc. following an inspection from February 25 to March 4, 2025, identifying significant Current Good Manufacturing Practice (CGMP) violations. The agency determined that the company"s drug products are adulterated due to these deficiencies. Furthermore, several of Uriel Pharmacy"s homeopathic ampule drug products, such as Aquilinum Taraxacum and Aurum 6X, are considered unapproved new drugs. A significant public health concern arises because these products, packaged in glass ampules, could be mistaken for injectable drugs, potentially leading to serious harm if misused.

Specific CGMP violations included a failure to establish and follow adequate control procedures for manufacturing processes and to validate their performance. The company also failed to conduct appropriate laboratory testing to verify the identity and strength of active ingredients, such as in Calendula 10%, Arnica 20%, and Viscum Mali 50, prior to product release. Inadequate aseptic manufacturing practices were observed, including improper cleaning methods and the use of non-sterile agents in cleanrooms, despite some products being processed for sterility. The regulatory framework cited includes 21 CFR parts 210 and 211, and sections 501(a)(2)(B), 505(a), and 301(d) of the FD&C Act.

Uriel Pharmacy is required to provide a comprehensive assessment of its in-process monitoring and sampling operations, a remediation plan to improve variation detection and controls, and a list of chemical specifications. If the company intends to produce sterile injectable drugs, it must fully comply with all CGMP requirements for sterile products, including validation of sterilization processes.