BioConnection B.V.
Form 483 issued March 8, 2024 · Oss, Netherlands
- Investigator
- Michael R. Shanks
- Observations
- 2
- Pages
- 1
- FEI number
- 3011445650
In short: On March 8, 2024, FDA issued a Form 483 with 2 observations to BioConnection B.V. in Oss, Netherlands (FEI 3011445650). The investigator was Michael R. Shanks. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.113 (1×) · 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your microbial cross-contamination control…
- 02
The environmental/personnel monitoring technique as described in Document WI-FC-007, rev. 4.0, effective date October 4, 2022…
This inspection in context
Michael R. Shanks
27 documents · 2017–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmBioConnection B.V. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BioConnection B.V.?
FDA listed 2 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected BioConnection B.V.?
Michael R. Shanks is named on this Form 483. Each investigator has a profile showing what they cite most.
When was BioConnection B.V. inspected by FDA?
This Form 483 is dated March 8, 2024.
How do I get the full Form 483 for BioConnection B.V.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.