Clinical Resolution Laboratory, Inc.
Form 483 issued April 27, 2021 · Brea, California
- Inspection
- Apr 6 – Apr 27, 2021
- Investigators
- Alan L. Truong· Claudia M. Perez-Kasmarski
- Observations
- 12
- Pages
- 18
- FEI number
- 3005727243
In short: On April 27, 2021, FDA issued a Form 483 with 12 observations to Clinical Resolution Laboratory, Inc. in Brea, California (FEI 3005727243) after an inspection that ran Apr 6 – Apr 27, 2021. The investigators were Alan L. Truong and Claudia M. Perez-Kasmarski. Most observations concern facilities & equipment and quality system.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 0121 CFR 21121 CFR 211.80
There is no quality control unit. ities, and procedures of your designated Quality…
- 02
Individuals responsible for supervising the manufacture, processing, packing and holding of a drug product lack the…
- 03
Complaint procedures are deficient in that written complaint files are not maintained at the manufacturing site…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Alan L. Truong
16 documents · 2019–2025
Cites 211.188 (batch production and control records) 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 211.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Clinical Resolution Laboratory, Inc.?
FDA listed 12 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 Clinical Resolution Laboratory, Inc.?
Alan L. Truong and Claudia M. Perez-Kasmarski are named on this Form 483, for the inspection of Apr 6 – Apr 27, 2021. Each investigator has a profile showing what they cite most.
When was Clinical Resolution Laboratory, Inc. inspected by FDA?
The inspection ran Apr 6 – Apr 27, 2021, and the Form 483 is dated April 27, 2021.
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.