Clinical Resolution Laboratory, Inc.
Form 483 issued January 16, 2025 · Brea, California
- Inspection
- Dec 11, 2024 – Jan 16, 2025
- Investigators
- Jean Claude Garay· Tyler Peterson· Vaishali J. Patel
- Observations
- 6
- Pages
- 16
- FEI number
- 3005727243
In short: On January 16, 2025, FDA issued a Form 483 with 6 observations to Clinical Resolution Laboratory, Inc. in Brea, California (FEI 3005727243) after an inspection that ran Dec 11, 2024 – Jan 16, 2025. The investigators were Jean Claude Garay, Tyler Peterson and Vaishali J. Patel. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
Quality system and production account for 4 of 6 observations.
Most cited: 21 CFR 211.198 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
products conform to appropriate standards of identity…
- 03
Procedures describing the handling of written and oral complaints related to drug products are…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Jean Claude Garay
4 documents · 2024–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Illinois.
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 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Clinical Resolution Laboratory, Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Clinical Resolution Laboratory, Inc.?
Jean Claude Garay, Tyler Peterson and Vaishali J. Patel are named on this Form 483, for the inspection of Dec 11, 2024 – Jan 16, 2025. Each investigator has a profile showing what they cite most.
When was Clinical Resolution Laboratory, Inc. inspected by FDA?
The inspection ran Dec 11, 2024 – Jan 16, 2025, and the Form 483 is dated January 16, 2025.
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.