Corerx, Inc.
Form 483 issued March 6, 2020 · CLEARWATER, Florida
- Inspection
- Feb 24 – Mar 6, 2020
- Investigator
- Kayla V. Sprague
- Observations
- 3
- Pages
- 4
- FEI number
- 3007209985
In short: On March 6, 2020, FDA issued a Form 483 with 3 observations to Corerx, Inc. in CLEARWATER, Florida (FEI 3007209985) after an inspection that ran Feb 24 – Mar 6, 2020. The investigator was Kayla V. Sprague. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations of a failure of a batch or any of its components to meet any of…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are…
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Corerx, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Corerx, Inc.?
Kayla V. Sprague is named on this Form 483, for the inspection of Feb 24 – Mar 6, 2020. Each investigator has a profile showing what they cite most.
When was Corerx, Inc. inspected by FDA?
The inspection ran Feb 24 – Mar 6, 2020, and the Form 483 is dated March 6, 2020.
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.