Revive Rx LLC dba Revive Rx Pharmacy
Form 483 issued August 6, 2021 · Houston, Texas
- Inspection
- Jul 20 – Aug 6, 2021
- Investigator
- Stephen D. Brown
- Observations
- 5
- Pages
- 2
- FEI number
- 3016710945
In short: On August 6, 2021, FDA issued a Form 483 with 5 observations to Revive Rx LLC dba Revive Rx Pharmacy in Houston, Texas (FEI 3016710945) after an inspection that ran Jul 20 – Aug 6, 2021. The investigator was Stephen D. Brown. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 5 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The certification of the ISO…
- 02
Observation 2: scanned text, readable in the full document.
- 03
M edia fills are not performed that closely simulate aseptic production operations, incorporating, as appropriate, worst…
- 04
Product intended to be sterile was exposed to lower than ISO…
This inspection in context
Stephen D. Brown
42 documents · 2006–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
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.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Revive Rx LLC dba Revive Rx Pharmacy?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Revive Rx LLC dba Revive Rx Pharmacy?
Stephen D. Brown is named on this Form 483, for the inspection of Jul 20 – Aug 6, 2021. 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 Jul 20 – Aug 6, 2021, and the Form 483 is dated August 6, 2021.
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.