Corerx, Inc.
FDA inspection history across 2 sites, 2014 to 2026
- 6
- Form 483s
Every document, by year
- Form 483
2014: one Form 483; 2019: two Form 483s; 2020: one Form 483; 2025: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014One Form 483, at CLEARWATER, Florida.
- 2019–20Three Form 483s, at CLEARWATER, Florida.
- 2025–26Two Form 483s, at Clearwater, Florida.
- 2026The longest 483 on file: 7 observations over 5 pages at Clearwater, Florida.
Cited most
Across all Corerx observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.68Automatic, mechanical, and electronic equipment4
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.160General requirements3
- 21 CFR 211.113Control of microbiological contamination2
The complete Corerx file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
CLEARWATER, Florida
Four Form 483s · 2014 to 2020 · 17 observations
Latest: Form 483, Mar 6, 2020 →Clearwater, Florida
One Form 483 · 2026 · 7 observations
Latest: Form 483, Feb 26, 2026 →
Also: one document not tied to a site.
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-02-26 | 483 Form 483 | Clearwater, Florida | 7 | $99 |
| 2025-03-20 | 483 Form 483 | — | — | $99 |
| 2020-03-06 | 483 Form 483 | CLEARWATER, Florida | 3 | $99 |
| 2019-06-21 | 483 Form 483 | CLEARWATER, Florida | 3 | $99 |
| 2019-06-14 | 483 Form 483 | CLEARWATER, Florida | 6 | $99 |
| 2014-01-24 | 483 Form 483 | CLEARWATER, Florida | 5 | $99 |
Investigators on these documents
Kayla V. Sprague (2)Jennifer Bridgewater (1)Jose Velez (1)Laura Fontan (1)Michael H. Tollon (1)Naveen B. Kanthamneni (1)Nicole E. Knowlton (1)Peng Zhou (1)Philippa Hillyer (1)Suzanne E. Lewis (1)Tammy T. Brown (1)Gregory Price (1)
FEI number 3007209985 · most recent document Feb 26, 2026
About Corerx, Inc.
How many FDA Form 483s has Corerx, Inc. received?
FDA Intel has 6 Form 483s on file for Corerx, Inc.; the most recent is dated Feb 26, 2026.
When was Corerx, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Corerx, Inc. is a Form 483 dated Feb 26, 2026, for the site in Clearwater, Florida.
What did FDA cite at Corerx, Inc.?
The regulations cited most in the observations on file for Corerx, Inc. are 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 4 times; 21 CFR 211.100 (Written procedures; deviations), 3 times.