Clinical Resolution Laboratory, Inc.
FDA inspection history in Brea, California, 2021 to 2025
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2021: one Form 483; 2022: one warning letter; 2023: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–25Three Form 483s and one warning letter, at Brea, California.
- 2021The longest 483 on file: 12 observations over 18 pages at Brea, California.
Cited most
Across all Clinical Resolution Laboratory observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.198Complaint files3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.63Equipment design, size, and location2
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
The complete Clinical Resolution Laboratory file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Brea, California
Three Form 483s and one warning letter · 2021 to 2025 · 25 observations
Latest: Form 483, Jan 16, 2025 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-01-16 | 483 Form 483 | Brea, California | 6 | $99 |
| 2023-09-29 | 483 Form 483 | Brea, California | 7 | $99 |
| 2022-03-01 | Warning letter Warning letter | Brea, California | — | $99 |
| 2021-04-27 | 483 Form 483 | Brea, California | 12 | $99 |
Investigators on these documents
Alan L. Truong (1)Bryan A. Galvez (1)Claudia M. Perez-Kasmarski (1)Jean Claude Garay (1)Tyler Peterson (1)Vaishali J. Patel (1)
FEI number 3005727243 · most recent document Jan 16, 2025
About Clinical Resolution Laboratory, Inc.
How many FDA Form 483s has Clinical Resolution Laboratory, Inc. received?
FDA Intel has 3 Form 483s on file for Clinical Resolution Laboratory, Inc.; the most recent is dated Jan 16, 2025.
When was Clinical Resolution Laboratory, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Clinical Resolution Laboratory, Inc. is a Form 483 dated Jan 16, 2025, for the site in Brea, California.
What did FDA cite at Clinical Resolution Laboratory, Inc.?
The regulations cited most in the observations on file for Clinical Resolution Laboratory, Inc. are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.198 (Complaint files), 3 times; 21 CFR 211.100 (Written procedures; deviations), 2 times.
Has Clinical Resolution Laboratory, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Clinical Resolution Laboratory, Inc.; the most recent is dated Mar 1, 2022.