Revive Rx LLC dba Revive Rx Pharmacy
Form 483 issued May 4, 2022 · Houston, Texas
- Inspection
- Apr 12 – May 4, 2022
- Investigator
- Camerson E. Moore
- Observations
- 9
- Pages
- 6
- FEI number
- 3016710945
In short: On May 4, 2022, FDA issued a Form 483 with 9 observations to Revive Rx LLC dba Revive Rx Pharmacy in Houston, Texas (FEI 3016710945) after an inspection that ran Apr 12 – May 4, 2022. The investigator was Camerson E. Moore. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 9 of 9 observations.
Most cited: 21 CFR 211.113 (5×) · 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel were observed conducting aseptic manipulations or placing equipment/supplies in an area that blocked the movement…
- 02
The intended to render final product sterile is not adequate to accomplish ............__-J and/or…
- 03
There is inadequate HEPA filter coverage or airflow over the area to which…
- 04
integrity testing to the…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
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 9 observations on this Form 483, mostly about production and facilities & equipment. 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?
Camerson E. Moore is named on this Form 483, for the inspection of Apr 12 – May 4, 2022. 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 Apr 12 – May 4, 2022, and the Form 483 is dated May 4, 2022.
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.