Catalent Belgium SA
FDA inspection history in Brussels, Belgium, 2016 to 2024
- 8
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2017: one Form 483; 2018: one Form 483; 2019: two Form 483s; 2021: one Form 483; 2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–24Eight Form 483s, at Brussels, Belgium.
- 2022The longest 483 on file: 9 observations over 10 pages at Brussels, Belgium.
Cited most
Across all Catalent Belgium observations on file
- 21 CFR 211.113Control of microbiological contamination12
- 21 CFR 211.100Written procedures; deviations5
- 21 CFR 211.110Sampling and testing of in-process materials and drug products3
- 21 CFR 211.192Production record review3
- 21 CFR 211.67Equipment cleaning and maintenance3
The complete Catalent Belgium file.
All 8 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Brussels, Belgium
Eight Form 483s · 2016 to 2024 · 46 observations
Latest: Form 483, Jul 12, 2024 →
Documents
8 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-12 | 483 Form 483 | Brussels, Belgium | 9 | $99 |
| 2022-08-19 | 483 Form 483 | Brussels, Belgium | 9 | $99 |
| 2021-10-26 | 483 Form 483 | Brussels, Belgium | 7 | $99 |
| 2019-06-19 | 483 Form 483 | Brussels, Belgium | 3 | $99 |
| 2019-02-15 | 483 Form 483 | Brussels, Belgium | 5 | $99 |
| 2018-07-31 | 483 Form 483 | Brussels, Belgium | 4 | $99 |
| 2017-07-07 | 483 Form 483 | Brussels, Belgium | 7 | $99 |
| 2016-11-25 | 483 Form 483 | Brussels, Belgium | 2 | $99 |
Investigators on these documents
Mihaly S. Ligmond (2)Gene D. Arcy (1)Hamet Tour (1)James W. Whitney (1)Jessica Hankins (1)Lindsey Brown (1)Lisa B. Orr (1)Susanne M. Richardson (1)Viviana Matta (1)Wayne Seifert (1)Yasamin Ameri (1)Ademola O. Daramola (1)
FEI number 3007647000 · most recent document Jul 12, 2024
About Catalent Belgium SA
How many FDA Form 483s has Catalent Belgium SA received?
FDA Intel has 8 Form 483s on file for Catalent Belgium SA; the most recent is dated Jul 12, 2024.
When was Catalent Belgium SA last inspected by FDA?
The most recent FDA inspection document on file for Catalent Belgium SA is a Form 483 dated Jul 12, 2024, for the site in Brussels, Belgium.
What did FDA cite at Catalent Belgium SA?
The regulations cited most in the observations on file for Catalent Belgium SA are 21 CFR 211.113 (Control of microbiological contamination), 12 times; 21 CFR 211.100 (Written procedures; deviations), 5 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 3 times.