Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-26.
At a glance
Inspections
8
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Sep 2025 – 26 Sep 2025 | Human Drugs | 483 | View 483 → |
| 9 Apr 2024 – 17 Apr 2024 | Foods & Cosmetics | Clean | |
| 23 Jun 2022 – 27 Jun 2022 | Foods & Cosmetics | Clean | |
| 19 May 2021 – 25 May 2021 | Human Drugs | Clean | |
| 30 Oct 2019 – 5 Nov 2019 | Human Drugs | Clean | |
| 13 Nov 2017 – 22 Nov 2017 | Human Drugs | 483 | View 483 → |
| 24 Mar 2015 – 31 Mar 2015 | Human Drugs | 483 | View 483 → |
| 27 May 2014 – 3 Jun 2014 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Sep 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jose O Hernandez, Emmanuel T Donyina
22 Nov 2017
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Jay T Wong, Alice S Tsao
22 Nov 2017
21 CFR 211.142
Written warehousing procedures established/followed
Cited by Jay T Wong, Alice S Tsao
Investigators
FDA investigators tied to this site in the record.
Meredith P Soehl2 insp.
Jay T Wong2 insp.
Jose O Hernandez1 insp.
Emmanuel T Donyina1 insp.
Gam S Zamil1 insp.
Brandy N Lepage1 insp.
Alice S Tsao1 insp.
Charisse K Green1 insp.
Sony Mathews1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.208 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind A&Z Pharmaceutical 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