Corerx, Inc.
Form 483 issued March 20, 2025
- Inspection
- Mar 12 – Mar 20, 2025
- Investigators
- Peng Zhou· Thai D. Truong
- Observations
- 6
- Pages
- 7
- FEI number
- 3007209985
In short: On March 20, 2025, FDA issued a Form 483 with 6 observations to Corerx, Inc. (FEI 3007209985) after an inspection that ran Mar 12 – Mar 20, 2025. The investigators were Peng Zhou and Thai D. Truong. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Written procedures are not established and followed for the cleaning and maintenance of equipment, including ,used…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Peng Zhou
15 documents · 2019–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Illinois.
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 6 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.?
Peng Zhou and Thai D. Truong are named on this Form 483, for the inspection of Mar 12 – Mar 20, 2025. Each investigator has a profile showing what they cite most.
When was Corerx, Inc. inspected by FDA?
The inspection ran Mar 12 – Mar 20, 2025, and the Form 483 is dated March 20, 2025.
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.