Corerx, Inc.
Form 483 issued January 24, 2014 · CLEARWATER, Florida
- Inspection
- Jan 14 – Jan 24, 2014
- Investigators
- Michael H. Tollon· Suzanne E. Lewis
- Observations
- 5
- Pages
- 4
- FEI number
- 3007209985
In short: On January 24, 2014, FDA issued a Form 483 with 5 observations to Corerx, Inc. in CLEARWATER, Florida (FEI 3007209985) after an inspection that ran Jan 14 – Jan 24, 2014. The investigators were Michael H. Tollon and Suzanne E. Lewis. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Written records of investigations into unexplained discrepancies do not always include…
- 03
Deviations from written production and process control procedures are…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Michael H. Tollon
12 documents · 2013–2024
Cites 211.42 (design and construction features) 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 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Corerx, Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Corerx, Inc.?
Michael H. Tollon and Suzanne E. Lewis are named on this Form 483, for the inspection of Jan 14 – Jan 24, 2014. Each investigator has a profile showing what they cite most.
When was Corerx, Inc. inspected by FDA?
The inspection ran Jan 14 – Jan 24, 2014, and the Form 483 is dated January 24, 2014.
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.