Overview
- 3 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
25 Apr 2013
21 CFR 211.65(a)
Equipment construction - reactive surfaces
Cited by Russell J Glapion, Linda L Ng, Richard L Rutherford, Xiaobin Shen
25 Apr 2013
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Russell J Glapion, Linda L Ng, Richard L Rutherford, Xiaobin Shen
25 Apr 2013
21 CFR 211.111
Deviations of production time limits
Cited by Russell J Glapion, Linda L Ng, Richard L Rutherford, Xiaobin Shen
Inspected site
GOGlaxo Operations UK LtdWare, United Kingdom
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.65(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 observations
Every observation in full, 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