Bio-Medical Pharmaceutical Manufacturing Corporation
FDA issued a warning letter to Bio-Medical Pharmaceutical Manufacturing Corporation (Houston, TX) following a August 2025 inspection that found significant CGMP violations in the manufacture of OTC sterile drug products. The facility lacked classified cleanrooms, ISO 5 aseptic filling conditions, validated sterilization and cleaning processes, and adequate release testing including sterility testing, rendering its drug products adulterated under section 501(a)(2)(B) of the FD&C Act. FDA also cited failure to list the drug product '(b)(4) Solution' in eDRLS and recommended removal of distributed batches from the U.S. market, which led to a voluntary recall by the distributor. The letter warns that failure to correct violations may result in seizure, injunction, withholding of export certificates, and denial of new drug application approvals.
Flagged claims (1)
Your firm erroneously indicated that your (b)(4) solution is not a drug product.
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.
We recommended you remove any batches of OTC (b)(4) solution (e.g., (b)(4) Solution) currently in distribution and within expiry from the U.S. market. We also recommended you consider ceasing further distribution.
Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP.
you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and 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 corrective actions and preventive actions before you pursue resolution of your firm's compliance status with FDA.
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