ProRx LLC
Form 483 issued September 9, 2025 · Exton, Pennsylvania
- Inspection
- Sep 9, 2025
- Investigator
- Taichun Qin
- Observations
- 7
- Pages
- 11
- FEI number
- 3022250654
In short: On September 9, 2025, FDA issued a Form 483 with 7 observations to ProRx LLC in Exton, Pennsylvania (FEI 3022250654) after an inspection that ran Sep 9, 2025. The investigator was Taichun Qin. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.42 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ProRx LLC?
FDA listed 7 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected ProRx LLC?
Taichun Qin is named on this Form 483, for the inspection of Sep 9, 2025. Each investigator has a profile showing what they cite most.
When was ProRx LLC inspected by FDA?
The inspection ran Sep 9, 2025, and the Form 483 is dated September 9, 2025.
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.