Overview
- 18 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.
23 Jun 2015
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Margaret M Annes, Philip F Istafanos
23 Jun 2015
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Margaret M Annes, Philip F Istafanos
23 Jun 2015
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Margaret M Annes, Philip F Istafanos
23 Jun 2015
21 CFR 211.194(a)
Complete test data included in records
Cited by Margaret M Annes, Philip F Istafanos
23 Jun 2015
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Margaret M Annes, Philip F Istafanos
Inspected site
GOGlaxo Operations UK LtdBarnard Castle, United Kingdom
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 3x |
Full 483 report
Get the verbatim text of all 18 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