Overview
- 10 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-12-20.
At a glance
Inspections
10
Form 483s
8
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Dec 2024 – 20 Dec 2024 | Human Drugs | 483 | View 483 → |
| 4 Jan 2024 – 11 Jan 2024 | Human Drugs | 483 | View 483 → |
| 28 Sep 2022 – 6 Oct 2022 | Human Drugs | 483 | View 483 → |
| 3 Dec 2019 – 16 Dec 2019 | Human Drugs | 483 | View 483 → |
| 15 Feb 2018 – 28 Feb 2018 | Human Drugs | 483 | View 483 → |
| 19 Oct 2015 – 2 Nov 2015 | Human Drugs | 483 | On file |
| 12 Dec 2013 – 23 Dec 2013 | Human Drugs | 483 | View 483 → |
| 19 Apr 2013 – 25 Apr 2013 | Human Drugs | Clean | |
| 20 Mar 2013 – 25 Mar 2013 | Human Drugs | 483 | On file |
| 4 Mar 2013 – 7 Mar 2013 | Foods & Cosmetics | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Dec 2024
21 CFR 211.176
Failing to test for penicillin cross-contamination
Cited by Karishma G Gopaul, Andrew O Ejiofor, Ifechimere I Okafor
20 Dec 2024
21 CFR 211.63
Equipment Design, Size and Location
Cited by Karishma G Gopaul, Andrew O Ejiofor, Ifechimere I Okafor
20 Dec 2024
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Karishma G Gopaul, Andrew O Ejiofor, Ifechimere I Okafor
11 Jan 2024
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Bijoy Panicker, Brandy N Lepage
Investigators
FDA investigators tied to this site in the record.
Bijoy Panicker2 insp.
Brandy N Lepage2 insp.
Mindy M Chou2 insp.
Helen B Ricalde2 insp.
Paul C Mouris2 insp.
Karishma G Gopaul1 insp.
Andrew O Ejiofor1 insp.
Ifechimere I Okafor1 insp.
Demitria J Xiradakis1 insp.
Sarah A Meehan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.176 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Chartwell Pharmaceuticals Carmel, 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