Overview
- 12 public-safe observations are available for this inspection.
- 11 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.
6 Jun 2019
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Omotunde O Osunsanmi, Darla J Christopher
6 Jun 2019
21 CFR 211.122(a)
Sampling/testing of labeling/packaging materials
Cited by Omotunde O Osunsanmi, Darla J Christopher
6 Jun 2019
21 CFR 211.122(d)
Labels and labeling stored separately
Cited by Omotunde O Osunsanmi, Darla J Christopher
6 Jun 2019
21 CFR 211.125(a)
Strict control not exercised over labeling issued
Cited by Omotunde O Osunsanmi, Darla J Christopher
6 Jun 2019
21 CFR 211.130(a)
Prevention of cross contamination, mix-ups
Cited by Omotunde O Osunsanmi, Darla J Christopher
Inspected site
GVGlaxoSmithKline Vaccines SrlSovicille, Italy
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.122(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.89 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 610.18(b) | Cited across public-safe Form 483 observations | 1x |
Source document
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Form 483 source document
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Full 483 report
Get the verbatim text of all 12 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