Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 5 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
29 Aug 2024
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Simone E Pitts, Marian E Ramirez, James Norman, Chunsheng Cai, Sarah C Zimmermann
29 Aug 2024
21 CFR 211.111
Establishment of time limitations
Cited by Simone E Pitts, Marian E Ramirez, James Norman, Chunsheng Cai, Sarah C Zimmermann
29 Aug 2024
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Simone E Pitts, Marian E Ramirez, James Norman, Chunsheng Cai, Sarah C Zimmermann
29 Aug 2024
21 CFR 211.166(a)
Lack of written stability program
Cited by Simone E Pitts, Marian E Ramirez, James Norman, Chunsheng Cai, Sarah C Zimmermann
29 Aug 2024
21 CFR 211.22(a)
Approve or reject components, products
Cited by Simone E Pitts, Marian E Ramirez, James Norman, Chunsheng Cai, Sarah C Zimmermann
Inspected site
NNNovo Nordisk Pharmaceutical Industries LPDurham, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | 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 6 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