Baxter Oncology GmbH
Form 483 issued November 5, 2019 · Halle/Westfalen, Germany
- Inspection
- Oct 28 – Nov 5, 2019
- Investigators
- Virginia A. Carroll· Zhong Li
- Observations
- 9
- Pages
- 4
- FEI number
- 3002806419
In short: On November 5, 2019, FDA issued a Form 483 with 9 observations to Baxter Oncology GmbH in Halle/Westfalen, Germany (FEI 3002806419) after an inspection that ran Oct 28 – Nov 5, 2019. The investigators were Virginia A. Carroll and Zhong Li. 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 7 of 9 observations.
Most cited: 21 CFR 211.113 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
The quality control unit lacks oversight of the inspection process of media-filled vials to support validation…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Cleaning validation of shared equipment is not adequate to ensure prevention…
This inspection in context
Virginia A. Carroll
5 documents · 2018–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
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 9 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 Baxter Oncology GmbH?
Virginia A. Carroll and Zhong Li are named on this Form 483, for the inspection of Oct 28 – Nov 5, 2019. Each investigator has a profile showing what they cite most.
When was Baxter Oncology GmbH inspected by FDA?
The inspection ran Oct 28 – Nov 5, 2019, and the Form 483 is dated November 5, 2019.
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.