Revive Rx LLC dba Revive Rx Pharmacy
Form 483 issued February 7, 2025 · Houston, Texas
- Inspection
- Jan 27 – Feb 7, 2025
- Investigator
- Jazmine N. Brown
- Observations
- 7
- Pages
- 7
- FEI number
- 3016710945
In short: On February 7, 2025, FDA issued a Form 483 with 7 observations to Revive Rx LLC dba Revive Rx Pharmacy in Houston, Texas (FEI 3016710945) after an inspection that ran Jan 27 – Feb 7, 2025. The investigator was Jazmine N. Brown.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Sterile clings and Materials were exposed to lower than…
- 02FDCA 501(a)(2)(A)
Microbial contamination was present in the ISO 5 area and areas…
- 03FDCA 501(a)(2)(A)
Lack of and Inadequate routine environmental monitoring in the ISO 5…
- 04FDCA 501(a)(2)(A)
Failure to conduct media fills that closely simulate aseptic production operations under the worst-case…
This inspection in context
Jazmine N. Brown
14 documents · 2022–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmRevive Rx LLC dba Revive Rx Pharmacy history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at Revive Rx LLC dba Revive Rx Pharmacy?
FDA listed 7 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Revive Rx LLC dba Revive Rx Pharmacy?
Jazmine N. Brown is named on this Form 483, for the inspection of Jan 27 – Feb 7, 2025. Each investigator has a profile showing what they cite most.
When was Revive Rx LLC dba Revive Rx Pharmacy inspected by FDA?
The inspection ran Jan 27 – Feb 7, 2025, and the Form 483 is dated February 7, 2025.
How do I get the full Form 483 for Revive Rx LLC dba Revive Rx Pharmacy?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.