Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
7 Feb 2020
21 CFR 211.100(a)
Approval and review of procedures
Cited by Roger F Zabinski, Renee S Blosser
7 Feb 2020
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Roger F Zabinski, Renee S Blosser
7 Feb 2020
21 CFR 211.101(d)
Component addition checked by 2nd person
Cited by Roger F Zabinski, Renee S Blosser
7 Feb 2020
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by Roger F Zabinski, Renee S Blosser
Inspected site
NLNorbrook Laboratories LimitedNewry, United Kingdom
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 211.101(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | 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