GlaxoSmithKline Biologicals
FDA inspection history in Saint-Amand Les Eaux, France, 2022 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–24Two Form 483s, at Saint-Amand Les Eaux, France.
- 2024The longest 483 on file: 3 observations over 6 pages at Saint-Amand Les Eaux, France.
Cited most
Across all GlaxoSmithKline Biologicals observations on file
- 21 CFR 211.67(b)(6)Equipment cleaning and maintenance2
- 21 CFR 211.170(b)Reserve samples1
- 21 CFR 211.192Production record review1
The complete GlaxoSmithKline Biologicals file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Saint-Amand Les Eaux, France
Two Form 483s · 2022 to 2024 · 4 observations
Latest: Form 483, Mar 12, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-03-12 | 483 Form 483 | Saint-Amand Les Eaux, France | 3 | $99 |
| 2022-09-13 | 483 Form 483 | Saint-Amand Les Eaux, France | 1 | $99 |
Investigators on these documents
FEI number 3014752610 · most recent document Mar 12, 2024
About GlaxoSmithKline Biologicals
How many FDA Form 483s has GlaxoSmithKline Biologicals received?
FDA Intel has 2 Form 483s on file for GlaxoSmithKline Biologicals; the most recent is dated Mar 12, 2024.
When was GlaxoSmithKline Biologicals last inspected by FDA?
The most recent FDA inspection document on file for GlaxoSmithKline Biologicals is a Form 483 dated Mar 12, 2024, for the site in Saint-Amand Les Eaux, France.
What did FDA cite at GlaxoSmithKline Biologicals?
The regulations cited most in the observations on file for GlaxoSmithKline Biologicals are 21 CFR 211.67(b)(6) (Equipment cleaning and maintenance), 2 times; 21 CFR 211.170(b) (Reserve samples), 1 time; 21 CFR 211.192 (Production record review), 1 time.