Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-10.
At a glance
Inspections
5
Form 483s
4
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Jan 2025 – 10 Jan 2025 | Human Drugs | Clean | |
| 4 Mar 2024 – 8 Mar 2024 | Human Drugs | 483 | On file |
| 27 Feb 2023 – 7 Mar 2023 | Human Drugs | 483 | On file |
| 26 Feb 2020 – 4 Mar 2020 | Biologics | 483 | View 483 → |
| 28 May 2018 – 1 Jun 2018 | Biologics | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Mar 2020
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Omotunde O Osunsanmi
4 Mar 2020
21 CFR 211.188(b)(7)
Documentation of Actual Yield and Theoretical Yield
Cited by Omotunde O Osunsanmi
Investigators
FDA investigators tied to this site in the record.
MRA MunizN1 insp.
Michael Shanks1 insp.
Lisa L Flores1 insp.
Monica E Murie1 insp.
Omotunde O Osunsanmi1 insp.
Burnell M Henry1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind BioConnection B.V.'s 4 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat