BioConnection B.V.
Form 483 issued March 4, 2020 · Oss, Netherlands
- Inspection
- Feb 26 – Mar 4, 2020
- Investigator
- Omotunde O. Osunsanmi
- Observations
- 8
- Pages
- 9
- FEI number
- 3011445650
In short: On March 4, 2020, FDA issued a Form 483 with 8 observations to BioConnection B.V. in Oss, Noord-Brabant (FEI 3011445650) after an inspection that ran Feb 26 – Mar 4, 2020. The investigator was Omotunde O. Osunsanmi. 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 6 of 8 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Omotunde O. Osunsanmi
13 documents · 2003–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in United Kingdom.
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(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BioConnection B.V.?
FDA listed 8 observations on this Form 483, mostly about production, facilities & equipment and quality system. 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.?
Omotunde O. Osunsanmi is named on this Form 483, for the inspection of Feb 26 – Mar 4, 2020. Each investigator has a profile showing what they cite most.
When was BioConnection B.V. inspected by FDA?
The inspection ran Feb 26 – Mar 4, 2020, and the Form 483 is dated March 4, 2020.
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.