Overview
- 3 public-safe observations are available for this inspection.
- 3 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.
26 Jul 2019
21 CFR 514.80(a)(1)
Applicant did not establish/maintain/keep complete safety/effectiveness records
Cited by Hugh M Mcclure, Dawn C Olenjack
26 Jul 2019
21 CFR 514.80(b)(4)
Timely submission of Periodic drug experience report
Cited by Hugh M Mcclure, Dawn C Olenjack
26 Jul 2019
21 CFR 514.80(b)(4)(iv)(B)
Periodic report did not note adverse drug experiences in literature
Cited by Hugh M Mcclure, Dawn C Olenjack
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 514.80(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 514.80(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 514.80(b)(4)(iv)(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 3 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