FDA Inspection
Revive Rx LLC dba Revive Rx PharmacyRevive Rx LLC dba Revive Rx Pharmacy – FDA Inspection, Feb 7, 2025
Record Details
This FDA Inspection record concerns Revive Rx LLC dba Revive Rx Pharmacy, with an inspection on February 7, 2025, issued by the Dallas District Office, covering human drugs.
- Office
- Dallas District Office
- Person
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ID · 954f2157-0655-46f2-9577-b0824725d0e6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1261213
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- FDCA 501(a)(2)(A)Exposed to lower quality air/ISO 5
- FDCA 501(a)(2)(A)Failure to clean and disinfect/sterilize equipment, ISO 5 area
- FDCA 501(a)(2)(A)Inadequate smoke studies
- FDCA 501(a)(2)(A)Lack of/inadequate, environmental monitoring
- FDCA 501(a)(2)(A)Lyophilizers, inadequately or not sterilized
- FDCA 501(a)(2)(A)Media fills, failure
- FDCA 501(a)(2)(A)Microbial contamination was present, ISO 5/areas adjacent
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Other FDA inspections of Revive Rx LLC dba Revive Rx Pharmacy
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 27, 2026 | Not classified | Dallas District Office | Drug Quality Assurance |
| May 4, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 6, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Revive Rx LLC dba Revive Rx Pharmacy
- FDA Inspection 1305262 - 2026-03-27
- FDA Inspection 1168666 - 2022-05-04
- FDA Inspection 1149791 - 2021-08-06
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