Overview
- 11 public-safe observations are available for this inspection.
- 10 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.
29 Jul 2024
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Daniel L Zheng, Lori M Newman, Ifechimere I Okafor
29 Jul 2024
21 CFR 211.101(d)
Component addition checked by 2nd person
Cited by Daniel L Zheng, Lori M Newman, Ifechimere I Okafor
29 Jul 2024
21 CFR 211.122(d)
Label storage access limited to authorized personnel
Cited by Daniel L Zheng, Lori M Newman, Ifechimere I Okafor
29 Jul 2024
21 CFR 211.125(a)
Strict control not exercised over labeling issued
Cited by Daniel L Zheng, Lori M Newman, Ifechimere I Okafor
29 Jul 2024
21 CFR 211.182
Written records kept in individual logs
Cited by Daniel L Zheng, Lori M Newman, Ifechimere I Okafor
Inspected site
DPDenison Pharmaceuticals, LLCLincoln, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.101(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(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 11 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