Overview
- 9 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-17.
At a glance
Inspections
9
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Jan 2025 – 17 Jan 2025 | Human Drugs | 483 | On file |
| 17 Jul 2023 – 24 Jul 2023 | Human Drugs | 483 | On file |
| 21 Apr 2022 – 27 Apr 2022 | Human Drugs | WL | On file |
| 2 Jun 2021 – 7 Jun 2021 | Human Drugs | 483 | On file |
| 1 Jun 2016 – 3 Jun 2016 | Human Drugs | Clean | |
| 1 Aug 2011 | Not recorded | 483 | On file |
| 19 Apr 2010 | Not recorded | Clean | |
| 13 May 2008 | Not recorded | 483 | On file |
| 22 Nov 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Jan 2025
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Darren S Brown, Tareq W Haddad
17 Jan 2025
21 CFR 211.166(a)(3)
Valid stability test methods
Cited by Darren S Brown, Tareq W Haddad
17 Jan 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Darren S Brown, Tareq W Haddad
17 Jan 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Darren S Brown, Tareq W Haddad
17 Jan 2025
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by Darren S Brown, Tareq W Haddad
Investigators
FDA investigators tied to this site in the record.
Rowena S Nguyen2 insp.
Roger F Zabinski2 insp.
Darren S Brown1 insp.
Tareq W Haddad1 insp.
Khoa Nathan V Tran1 insp.
Sara H Gabel1 insp.
Rachel C Stanton1 insp.
Taichun Qin1 insp.
Crystal Monroy1 insp.
Sonia R Peterson1 insp.
John R Myung1 insp.
Kelvin X Sanders1 insp.
Cntrctmntr Kelley1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Advanced Cosmetic Research Laboratories' 6 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