Corerx, Inc.
Form 483 issued June 21, 2019 · CLEARWATER, Florida
- Inspection
- Jun 17 – Jun 21, 2019
- Investigators
- Jose Velez· Naveen B. Kanthamneni
- Observations
- 3
- Pages
- 3
- FEI number
- 3007209985
In short: On June 21, 2019, FDA issued a Form 483 with 3 observations to Corerx, Inc. in CLEARWATER, Florida (FEI 3007209985) after an inspection that ran Jun 17 – Jun 21, 2019. The investigators were Jose Velez and Naveen B. Kanthamneni. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls 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
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
Records of the calibration checks and inspections of automatic, mechanical or electronic equipment, including computers or…
- 03
BPLOYEE(S) SIGNATURE DATEISSUED Investigations of a failure of a batch or any of its components to…
This inspection in context
Jose Velez
24 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
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 211.160
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 laboratory controls, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Corerx, Inc.?
Jose Velez and Naveen B. Kanthamneni are named on this Form 483, for the inspection of Jun 17 – Jun 21, 2019. Each investigator has a profile showing what they cite most.
When was Corerx, Inc. inspected by FDA?
The inspection ran Jun 17 – Jun 21, 2019, and the Form 483 is dated June 21, 2019.
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.