BioConnection B.V.
FDA inspection history in Oss, Netherlands, 2018 to 2024
- 3
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2020: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–20Two Form 483s, at Oss, Netherlands.
- 2020The longest 483 on file: 8 observations over 9 pages at Oss, Netherlands.
- 2024One Form 483, at Oss, Netherlands.
Cited most
Across all BioConnection B.V. observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.160General requirements2
- 21 CFR 601.12Changes to an approved application2
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
The complete BioConnection B.V. file.
All 3 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
Oss, Netherlands
Three Form 483s · 2018 to 2024 · 17 observations
Latest: Form 483, Mar 8, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-03-08 | 483 Form 483 | Oss, Netherlands | 2 | $99 |
| 2020-03-04 | 483 Form 483 | Oss, Netherlands | 8 | $99 |
| 2018-06-01 | 483 Form 483 | Oss, Netherlands | 7 | $99 |
Investigators on these documents
Burnell M. Henry (1)Ewa Marszal (1)Michael R. Shanks (1)Omotunde O. Osunsanmi (1)
FEI number 3011445650 · most recent document Mar 8, 2024
About BioConnection B.V.
How many FDA Form 483s has BioConnection B.V. received?
FDA Intel has 3 Form 483s on file for BioConnection B.V.; the most recent is dated Mar 8, 2024.
When was BioConnection B.V. last inspected by FDA?
The most recent FDA inspection document on file for BioConnection B.V. is a Form 483 dated Mar 8, 2024, for the site in Oss, Netherlands.
What did FDA cite at BioConnection B.V.?
The regulations cited most in the observations on file for BioConnection B.V. are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.42 (Design and construction features), 3 times; 21 CFR 211.160 (General requirements), 2 times.