BioConnection B.V.
Form 483 issued June 1, 2018 · Oss, Netherlands
- Inspection
- May 28 – Jun 1, 2018
- Investigators
- Burnell M. Henry· Ewa Marszal
- Observations
- 7
- Pages
- 3
- FEI number
- 3011445650
In short: On June 1, 2018, FDA issued a Form 483 with 7 observations to BioConnection B.V. in Oss, Netherlands (FEI 3011445650) after an inspection that ran May 28 – Jun 1, 2018. The investigators were Burnell M. Henry and Ewa Marszal. Most observations concern laboratory controls and biologics CGMP; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and biologics cgmp account for 5 of 7 observations.
Most cited: 21 CFR 211.160 (2×) · 601.12 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Studies designed to validate…
- 02
There is a failure to reject any lot of components that did not meet the appropriate…
- 03
Growth promotion studies fail to provide assurance of consistent organism recoveries…
- 04
The following manufacturing and analytical changes were not properly reported to FDA…
This inspection in context
Burnell M. Henry
22 documents · 2012–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in North Carolina.
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BioConnection B.V.?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, biologics CGMP and materials. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected BioConnection B.V.?
Burnell M. Henry and Ewa Marszal are named on this Form 483, for the inspection of May 28 – Jun 1, 2018. Each investigator has a profile showing what they cite most.
When was BioConnection B.V. inspected by FDA?
The inspection ran May 28 – Jun 1, 2018, and the Form 483 is dated June 1, 2018.
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.