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# Revive Rx FDA-483 Has 5 Repeat Observations
- URL: https://www.fdaweb.com/revive-rx-fda-483-has-5-repeat-observations/
- Published: 2026-04-23T12:00:00.000Z
- Updated: 2026-09-14T13:37:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161037

FDA has released the form FDA-483 with five observations from a 3/9-3/27 inspection at Revive Rx, doing business as Revive Rx Pharmacy, a Houston, TX, producer of sterile and non-sterile drugs. The specific repeat inspection [observations](https://www.fda.gov/media/192056/download?ref=fdaweb.com) were:

- microbial contamination was present in the ISO 5 area and areas adjacent to production areas;
- lack of adequate personnel sampling;
- smoke studies were not performed under dynamic conditions;
- sterile drugs and materials were exposed to lower than ISO 5 quality air; and
- use of redacted items that are not sterilized by routine sterilization cycles and protected from contamination by sterilizing redacted on vacuum break air lines/vents.