Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
6 Mar 2020
21 CFR 117.135(c)(1)
Process Controls Procedures - Adequate
Cited by Victoria L Palmer, N'Jere English, Laura D Cain, Kristin M Hester-Jackson
6 Mar 2020
21 CFR 117.135(c)(3)
Sanitation Controls Procedures
Cited by Victoria L Palmer, N'Jere English, Laura D Cain, Kristin M Hester-Jackson
6 Mar 2020
21 CFR 117.145(a)
Process Controls Monitoring Procedures: Establish Implement
Cited by Victoria L Palmer, N'Jere English, Laura D Cain, Kristin M Hester-Jackson
6 Mar 2020
21 CFR 117.145(b)
Process Controls Monitoring Frequency
Cited by Victoria L Palmer, N'Jere English, Laura D Cain, Kristin M Hester-Jackson
6 Mar 2020
21 CFR 117.150(d)
Process Controls Corrective Action Records
Cited by Victoria L Palmer, N'Jere English, Laura D Cain, Kristin M Hester-Jackson
Inspected site
DNDoehler North America, Inc.Cartersville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.135(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.135(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.145(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.145(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.150(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.320 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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