Biologics X. Ante
FDA investigator
Appears on 1 document from 2024, mostly at sites in Italy. Most often cites general requirements (21 CFR 211.160(a)).
- 1
- Documents on file
- 5.0
- Observations per 483
- 2024
- First seen
- 2024
- Most recent
What they cite most
From 5 observations- 21 CFR 211.160(a)General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.25(a)Personnel qualifications1
- 21 CFR 314.80(c)(1)(i)Postmarketing reporting of adverse drug experiences1
Activity by year
2024: 1
Where
Italy 1
Often inspects with
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Inspection history
1 document, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-01-26 | 483 GlaxoSmithKline Vaccines SrlJan 26, 2024 · Sovicille, Italy | Sovicille, Italy | 5 |
About this profile
What does Biologics X. Ante inspect?
Biologics X. Ante appears on 1 document on file covering 1 site, mostly in Italy.
What do they cite most often?
21 CFR 211.160(a) (general requirements), followed by 21 CFR 211.192 and 21 CFR 211.22(d).
Can I read the observations?
Each document page previews the opening words of every observation. The full documents are available to buy, one at a time or together.
How current is this profile?
The most recent document on file for Biologics X. Ante is dated Jan 26, 2024.