Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-12-18.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Dec 2024 – 18 Dec 2024 | Human Drugs | 483 | View 483 → |
| 15 Sep 2017 – 18 Sep 2017 | Human Drugs | Clean | |
| 17 May 2016 – 25 May 2016 | Human Drugs | 483 | View 483 → |
| 5 Sep 2013 – 6 Sep 2013 | Human Drugs | Clean | |
| 7 Sep 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Dec 2024
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Anthony J Donato, Rohan P Sridhar
18 Dec 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Anthony J Donato, Rohan P Sridhar
18 Dec 2024
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Anthony J Donato, Rohan P Sridhar
25 May 2016
21 CFR 314.80(c)(2)(ii)(A)
Incomplete periodic safety report
Cited by Yvesna C Blaise, Jose M Cayuela
25 May 2016
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Yvesna C Blaise, Jose M Cayuela
Investigators
FDA investigators tied to this site in the record.
Michael R Klapal2 insp.
Anthony J Donato1 insp.
Rohan P Sridhar1 insp.
Nancy F Scheraga1 insp.
Yvesna C Blaise1 insp.
Jose M Cayuela1 insp.
Michael Serrano1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Chartwell Pharmaceuticals West Caldwell, LLC.'s 2 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