Corerx, Inc.
Form 483 issued February 26, 2026 · Clearwater, Florida
- Inspection
- Feb 23 – Feb 26, 2026
- Investigators
- Kayla V. Sprague· Nicole E. Knowlton· Tammy T. Brown
- Observations
- 7
- Pages
- 5
- FEI number
- 3007209985
In short: On February 26, 2026, FDA issued a Form 483 with 7 observations to Corerx, Inc. in Clearwater, Florida (FEI 3007209985) after an inspection that ran Feb 23 – Feb 26, 2026. The investigators were Kayla V. Sprague, Nicole E. Knowlton and Tammy T. Brown. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Facilities & equipment and production account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Component testing is deficient in that each component is not tested for conformity with all appropriate…
- 03
The number of containers to De sampled and amount of material taken from each container is…
- 04
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not…
This inspection in context
Kayla V. Sprague
17 documents · 2020–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Florida.
The firmCorerx, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Corerx, Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Corerx, Inc.?
Kayla V. Sprague, Nicole E. Knowlton and Tammy T. Brown are named on this Form 483, for the inspection of Feb 23 – Feb 26, 2026. Each investigator has a profile showing what they cite most.
When was Corerx, Inc. inspected by FDA?
The inspection ran Feb 23 – Feb 26, 2026, and the Form 483 is dated February 26, 2026.
How do I get the full Form 483 for Corerx, Inc.?
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.