Revive Rx LLC dba Revive Rx Pharmacy
FDA issued a warning letter to Revive Rx LLC dba Revive Rx Pharmacy (Houston, TX) following a January–February 2025 inspection that identified serious insanitary conditions in sterile drug compounding operations. The facility exposed sterile drug products to worse than ISO-classified air quality, failed to perform adequate media fills and smoke studies under dynamic conditions, and did not conduct sufficient environmental monitoring in aseptic processing areas. FDA found these practices caused drug products to be adulterated under section 501(a)(2)(A) of the FDCA, and the firm's corrective action responses were deemed deficient or insufficiently documented. The agency warned that failure to adequately address violations may result in seizure or injunction.
Required actions (2)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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