Overview
- 14 FDA inspections are on record.
- 13 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-18.
At a glance
Inspections
14
Form 483s
13
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Oct 2025 – 18 Nov 2025 | Human Drugs | 483 | View 483 → |
| 9 Dec 2024 – 19 Dec 2024 | Human Drugs | 483 | On file |
| 21 May 2024 – 31 May 2024 | Human Drugs | 483 | On file |
| 21 May 2024 – 31 May 2024 | Human Drugs | 483 | On file |
| 21 May 2024 – 31 May 2024 | Human Drugs | 483 | On file |
| 21 May 2024 – 31 May 2024 | Human Drugs | 483 | On file |
| 21 May 2024 – 31 May 2024 | Human Drugs | 483 | On file |
| 1 Apr 2024 – 8 Apr 2024 | Human Drugs | 483 | On file |
| 1 May 2023 – 24 May 2023 | Human Drugs | 483 | On file |
| 12 Sep 2018 – 26 Sep 2018 | Human Drugs | 483 | On file |
| 27 Oct 2016 – 1 Nov 2016 | Human Drugs | 483 | On file |
| 27 Apr 2015 – 1 May 2015 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Nov 2025
21 CFR 211.100(a)
Changes to Procedures Not Reviewed, Approved
Cited by Lata C Mathew, Mindy M Chou, Syeda N Mahazabin
18 Nov 2025
21 CFR 211.101(b)
Identification of new containers
Cited by Lata C Mathew, Mindy M Chou, Syeda N Mahazabin
18 Nov 2025
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Lata C Mathew, Mindy M Chou, Syeda N Mahazabin
18 Nov 2025
21 CFR 211.160(b)(2)
In-process sample representation/identification
Cited by Lata C Mathew, Mindy M Chou, Syeda N Mahazabin
18 Nov 2025
21 CFR 211.166(a)
Written program not followed
Cited by Lata C Mathew, Mindy M Chou, Syeda N Mahazabin
Investigators
FDA investigators tied to this site in the record.
Josh Renzo N Ramilo5 insp.
JoshRenzo N Ramilo5 insp.
Stephenie M Ortiz5 insp.
John D Mcintosh5 insp.
Sony Mathews3 insp.
Lata C Mathew1 insp.
Mindy M Chou1 insp.
Syeda N Mahazabin1 insp.
Alisha B Patel1 insp.
Asia D Clark1 insp.
Robin P Mathew1 insp.
Ankur C Patel1 insp.
Helen B Ricalde1 insp.
Satheesh Thomas1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.101(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(2) | 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(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.176 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(b) | 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(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Chartwell Pharmaceuticals Congers, LLC's 13 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