Overview
- 8 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-12-09.
At a glance
Inspections
8
Form 483s
8
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Dec 2024 – 9 Dec 2024 | Foods & Cosmetics | 483 | On file |
| 10 Nov 2022 – 21 Nov 2022 | Foods & Cosmetics | 483 | On file |
| 5 Oct 2021 – 14 Oct 2021 | Foods & Cosmetics | 483 | On file |
| 8 Mar 2018 – 29 Mar 2018 | Foods & Cosmetics | 483 | On file |
| 23 Feb 2016 – 9 Mar 2016 | Foods & Cosmetics | WL | On file |
| 14 Jul 2014 – 18 Jul 2014 | Foods & Cosmetics | 483 | On file |
| 28 Jun 2013 – 11 Jul 2013 | Foods & Cosmetics | 483 | On file |
| 4 Oct 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Dec 2024
21 CFR 111.315(d)
Standard reference materials; criteria for selecting
Cited by Meredith P Soehl
Investigators
FDA investigators tied to this site in the record.
Meredith P Soehl5 insp.
Erica B Raphael1 insp.
Erica B Brush1 insp.
Christopher S Fields1 insp.
Yuyan Liang1 insp.
Andrew J Garufi1 insp.
Charanjeet Jassal1 insp.
Kwong P Lee1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.315(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.95(b)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.113(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.35(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.73 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 2x |
| FDCA 761(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.155(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(l)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.320(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.325(b)(2)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.360 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.430(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.560(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.605 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.90(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind AJES Pharmaceuticals, LLC's 8 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