Uriel Pharmacy, Inc.
FDA issued a warning letter to Uriel Pharmacy, Inc. (East Troy, WI) following a February–March 2025 inspection that found significant CGMP violations including inadequate in-process testing, component identity testing failures, and deficient quality control unit oversight. In addition, FDA determined that seven homeopathic ampule drug products sold on shopuriel.com are unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act, with serious public health concerns because the glass ampule packaging mimics sterile injectable containers and the products have been documented being injected by clinicians despite oral-use labeling. FDA warned that failure to correct violations may result in seizure, injunction, withholding of export certificates, and denial of new drug applications, and required a written response within 15 working days.
Flagged claims (5)
Use: Promotes healing of broken bones.
Use: Temporary relief of headache.
Use: Temporary relief of flu symptoms.
Use: Temporary relief of digestive upset.
Use: Temporary relief of upset stomach.
Required actions (5)
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.
you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPAs before you pursue resolution of your firm's compliance status with FDA.
Failure to adequately address this matter may lead to regulatory or legal action without further notice including, without limitation, seizure and injunction.
A commitment to provide DEG and EG test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products.
If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.
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