Baxter Oncology GmbH
Form 483 issued August 27, 2024 · Halle Westfalen, Germany
- Inspection
- Aug 19 – Aug 27, 2024
- Investigators
- Bingchen Du· Sudipan Karmaker· Wayne Seifert
- Observations
- 6
- Pages
- 3
- FEI number
- 3002806419
In short: On August 27, 2024, FDA issued a Form 483 with 6 observations to Baxter Oncology GmbH in Halle Westfalen, Germany (FEI 3002806419) after an inspection that ran Aug 19 – Aug 27, 2024. The investigators were Bingchen Du, Sudipan Karmaker and Wayne Seifert. 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 5 of 6 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to establish process, procedural controls and testing designed to assure that the drug products you…
- 02
Calibrations to a specification in support of (b)(4) drug product…
- 03
The (b)(4) drug substance (DS)…
- 04
A validation in support of (b)(4) drug…
This inspection in context
Bingchen Du
2 documents · 2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Germany.
The firmBaxter Oncology GmbH history
All 5 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 Baxter Oncology GmbH?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and materials. 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 Baxter Oncology GmbH?
Bingchen Du, Sudipan Karmaker and Wayne Seifert are named on this Form 483, for the inspection of Aug 19 – Aug 27, 2024. Each investigator has a profile showing what they cite most.
When was Baxter Oncology GmbH inspected by FDA?
The inspection ran Aug 19 – Aug 27, 2024, and the Form 483 is dated August 27, 2024.
How do I get the full Form 483 for Baxter Oncology GmbH?
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.