Baxter Oncology GmbH
Form 483 issued September 26, 2025 · Halle (Westf.), Germany
- Inspection
- Sep 18 – Sep 26, 2025
- Investigators
- Justin A. Boyd· Karen A. Briggs· Vivin George
- Observations
- 12
- Pages
- 17
- FEI number
- 3002806419
In short: On September 26, 2025, FDA issued a Form 483 with 12 observations to Baxter Oncology GmbH in Halle (Westf.), North Rhine-Westphalia (FEI 3002806419) after an inspection that ran Sep 18 – Sep 26, 2025. The investigators were Justin A. Boyd, Karen A. Briggs and Vivin George. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Facilities & equipment and production account for 9 of 12 observations.
Most cited: 21 CFR 211.113(b) (2×) · 211.42(c)(10)(iv) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of ding products purporting to be sterile did not include…
- 02
Procedures designed to prevent microbiological contamination of dnig products purporting to be sterile are not established…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Equipment used in the manufacture, processing, packing or holding of ding products is not of appropriate…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Baxter Oncology GmbH?
FDA listed 12 observations on this Form 483, mostly about facilities & equipment, production 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 Baxter Oncology GmbH?
Justin A. Boyd, Karen A. Briggs and Vivin George are named on this Form 483, for the inspection of Sep 18 – Sep 26, 2025. Each investigator has a profile showing what they cite most.
When was Baxter Oncology GmbH inspected by FDA?
The inspection ran Sep 18 – Sep 26, 2025, and the Form 483 is dated September 26, 2025.
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.