Corerx, Inc.
Form 483 issued June 14, 2019 · CLEARWATER, Florida
- Inspection
- Jun 10 – Jun 14, 2019
- Investigators
- Gregory Price· Jennifer Bridgewater· Laura Fontan
- Observations
- 6
- Pages
- 3
- FEI number
- 3007209985
In short: On June 14, 2019, FDA issued a Form 483 with 6 observations to Corerx, Inc. in CLEARWATER, Florida (FEI 3007209985) after an inspection that ran Jun 10 – Jun 14, 2019. The investigators were Gregory Price, Jennifer Bridgewater, Laura Fontan and Philippa Hillyer. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
4 of 6 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.160 (2×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The (b) (4) Method described in SOP-0387 as an in-process drug product control…
- 02
Quality procedures are not…
- 03
Adequate precaution is not taken to avoid…
- 04
Documentation of Major and Minor…
This inspection in context
Gregory Price
3 documents · 2019–2023
Cites 211.160 (general requirements) 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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Corerx, Inc.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Corerx, Inc.?
Gregory Price, Jennifer Bridgewater, Laura Fontan and Philippa Hillyer are named on this Form 483, for the inspection of Jun 10 – Jun 14, 2019. Each investigator has a profile showing what they cite most.
When was Corerx, Inc. inspected by FDA?
The inspection ran Jun 10 – Jun 14, 2019, and the Form 483 is dated June 14, 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.