Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
31 May 2024
21 CFR 211.100(a)
Changes to Procedures Not Reviewed, Approved
Cited by Stephenie M Ortiz, John D Mcintosh, JoshRenzo N Ramilo
31 May 2024
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Stephenie M Ortiz, John D Mcintosh, JoshRenzo N Ramilo
31 May 2024
21 CFR 211.160(b)(3)
Drug products-sampling procedures/specifications
Cited by Stephenie M Ortiz, John D Mcintosh, JoshRenzo N Ramilo
31 May 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Stephenie M Ortiz, John D Mcintosh, JoshRenzo N Ramilo
31 May 2024
21 CFR 211.63
Equipment Design, Size and Location
Cited by Stephenie M Ortiz, John D Mcintosh, JoshRenzo N Ramilo
Inspected site
CPChartwell Pharmaceuticals Congers, LLCCongers, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 observations
The full inspection record, as Atlas holds it, 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