Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-16.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Jan 2025 – 16 Jan 2025 | Human Drugs | 483 | View 483 → |
| 7 Aug 2024 – 12 Aug 2024 | Foods & Cosmetics | Clean | |
| 18 Sep 2023 – 29 Sep 2023 | Human Drugs | 483 | View 483 → |
| 6 Apr 2021 – 27 Apr 2021 | Human Drugs | WL | View 483 → |
| 8 May 2018 – 15 May 2018 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Jan 2025
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Khoa Nathan V Tran, Thuy Tram L Nguyen
16 Jan 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Khoa Nathan V Tran, Thuy Tram L Nguyen
16 Jan 2025
21 CFR 211.63
Equipment Design, Size and Location
Cited by Khoa Nathan V Tran, Thuy Tram L Nguyen
16 Jan 2025
21 CFR 211.84(d)(2)
Component written specification
Cited by Khoa Nathan V Tran, Thuy Tram L Nguyen
Investigators
FDA investigators tied to this site in the record.
Bryan A Galvez2 insp.
Khoa Nathan V Tran1 insp.
Thuy Tram L Nguyen1 insp.
Patricia F Alberico1 insp.
Alan L Truong1 insp.
Claudia M Perez-Kasmarski1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.198(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.25(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(8) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Clinical Resolution Laboratory, Inc.'s 4 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat