Overview
- 3 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
CPChartwell Pharmaceuticals West Caldwell, LLC.West Caldwell, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| 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 |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 3 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere