Overview
- 16 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-27.
At a glance
Inspections
16
Form 483s
10
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Feb 2025 – 27 Feb 2025 | Human Drugs | 483 | View 483 → |
| 26 Nov 2018 – 13 Dec 2018 | Human Drugs | 483 | View 483 → |
| 22 Jun 2017 – 6 Jul 2017 | Human Drugs | 483 | View 483 → |
| 12 Nov 2015 – 2 Dec 2015 | Human Drugs | 483 | View 483 → |
| 25 Feb 2015 – 6 Mar 2015 | Human Drugs | 483 | View 483 → |
| 10 Dec 2013 – 19 Dec 2013 | Human Drugs | 483 | View 483 → |
| 25 Jun 2013 – 2 Jul 2013 | Human Drugs | 483 | View 483 → |
| 11 Jan 2013 | Not recorded | 483 | View 483 → |
| 9 Dec 2011 | Not recorded | 483 | View 483 → |
| 14 Feb 2011 | Not recorded | 483 | View 483 → |
| 15 Apr 2010 | Not recorded | Clean | |
| 17 Sep 2009 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Feb 2025
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Tanya R Syffrard, Luxuly Abraham
27 Feb 2025
21 CFR 211.80(b)
Handling and Storage to Prevent Contamination
Cited by Tanya R Syffrard, Luxuly Abraham
Investigators
FDA investigators tied to this site in the record.
Robert C Horan4 insp.
Charisse K Green2 insp.
Tanya R Syffrard1 insp.
Luxuly Abraham1 insp.
Sony Mathews1 insp.
Jose O Hernandez1 insp.
Rachael A Moliver1 insp.
Samina S Khan1 insp.
Demitria J Xiradakis1 insp.
Alice S Tsao1 insp.
Uduak M Inokon1 insp.
Thomas J Mooney1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(c)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Advance Pharmaceutical, Inc.'s 10 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