ProRx LLC
FDA inspection history in Exton, Pennsylvania, 2024 to 2026
- 3
- Form 483s
- 2
- Warning letters
Every document, by year
- Warning letter
- Form 483
2024: one Form 483; 2025: two Form 483s and one warning letter; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2024–26Three Form 483s and two warning letters, at Exton, Pennsylvania.
- 2024The longest 483 on file: 13 observations over 14 pages at Exton, Pennsylvania.
Cited most
Across all ProRx observations on file
- 21 CFR 211.113Control of microbiological contamination6
- 21 CFR 211.42Design and construction features6
- 21 CFR 211.192Production record review3
- 21 CFR 211.22Responsibilities of quality control unit3
- FDCA 503B(a)(10)(A)2
The complete ProRx file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Exton, Pennsylvania
Three Form 483s and two warning letters · 2024 to 2026 · 27 observations
Latest: Warning letter, Apr 7, 2026 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-04-07 | Warning letter Warning letter | Exton, Pennsylvania | — | $99 |
| 2025-09-19 | 483 Form 483 | Exton, Pennsylvania | 7 | $99 |
| 2025-09-09 | 483 Form 483 | Exton, Pennsylvania | 7 | $99 |
| 2025-03-04 | Warning letter Warning letter | Exton, Pennsylvania | — | $99 |
| 2024-08-02 | 483 Form 483 | Exton, Pennsylvania | 13 | $99 |
Investigators on these documents
FEI number 3022250654 · most recent document Apr 7, 2026
About ProRx LLC
How many FDA Form 483s has ProRx LLC received?
FDA Intel has 3 Form 483s on file for ProRx LLC; the most recent is dated Sep 19, 2025.
When was ProRx LLC last inspected by FDA?
The most recent FDA inspection document on file for ProRx LLC is a Form 483 dated Sep 19, 2025, for the site in Exton, Pennsylvania.
What did FDA cite at ProRx LLC?
The regulations cited most in the observations on file for ProRx LLC are 21 CFR 211.113 (Control of microbiological contamination), 6 times; 21 CFR 211.42 (Design and construction features), 6 times; 21 CFR 211.192 (Production record review), 3 times.
Has ProRx LLC received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for ProRx LLC; the most recent is dated Apr 7, 2026.