Clinical Resolution Laboratory, Inc.
Form 483 issued September 29, 2023 · Brea, California
- Inspection
- Sep 18 – Sep 29, 2023
- Investigator
- Bryan A. Galvez
- Observations
- 7
- Pages
- 7
- FEI number
- 3005727243
In short: On September 29, 2023, FDA issued a Form 483 with 7 observations to Clinical Resolution Laboratory, Inc. in Brea, California (FEI 3005727243) after an inspection that ran Sep 18 – Sep 29, 2023. The investigator was Bryan A. Galvez. Most observations concern quality system and laboratory controls.
At a glance
Observations span 4 systems, led by quality system.
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
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
This inspection in context
Bryan A. Galvez
15 documents · 2018–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmClinical Resolution Laboratory, Inc. history
All 4 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 Clinical Resolution Laboratory, Inc.?
FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Clinical Resolution Laboratory, Inc.?
Bryan A. Galvez is named on this Form 483, for the inspection of Sep 18 – Sep 29, 2023. Each investigator has a profile showing what they cite most.
When was Clinical Resolution Laboratory, Inc. inspected by FDA?
The inspection ran Sep 18 – Sep 29, 2023, and the Form 483 is dated September 29, 2023.
How do I get the full Form 483 for Clinical Resolution Laboratory, 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.