ProRx LLC
Form 483 issued August 2, 2024 · Exton, Pennsylvania
- Inspection
- Jul 15 – Aug 2, 2024
- Investigators
- Jazmine N. Brown· Karishma G. Gopaul
- Observations
- 13
- Pages
- 14
- FEI number
- 3022250654
In short: On August 2, 2024, FDA issued a Form 483 with 13 observations to ProRx LLC in Exton, Pennsylvania (FEI 3022250654) after an inspection that ran Jul 15 – Aug 2, 2024. The investigators were Jazmine N. Brown and Karishma G. Gopaul. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
The responsibilities and procedures applicable to the quality…
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 firmProRx LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ProRx LLC?
FDA listed 13 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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 ProRx LLC?
Jazmine N. Brown and Karishma G. Gopaul are named on this Form 483, for the inspection of Jul 15 – Aug 2, 2024. Each investigator has a profile showing what they cite most.
When was ProRx LLC inspected by FDA?
The inspection ran Jul 15 – Aug 2, 2024, and the Form 483 is dated August 2, 2024.
How do I get the full Form 483 for ProRx LLC?
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.