Revive Rx LLC dba Revive Rx Pharmacy – FDA 483, May 4, 2022
An FDA inspection of Revive Rx LLC dba Revive Rx Pharmacy in Houston, TX, revealed significant deficiencies in aseptic processing, cleanroom environment control, and equipment validation. Observations included poor aseptic techniques, inadequate sterile filtration, insufficient HEPA filter coverage, and improper cleanroom design and maintenance. These issues indicate a serious lack of control over sterile drug product manufacturing, leading to the disposal of multiple drug lots.
ID · d62df77c-3e9d-4646-afd0-17c80f817623
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