Baxter Oncology GmbH
Form 483 issued June 14, 2018 · Halle/Westfalen, Germany
- Inspection
- Jun 4 – Jun 14, 2018
- Investigators
- Emilie Kahn· Luis M. Burges
- Observations
- 4
- Pages
- 3
- FEI number
- 3002806419
In short: On June 14, 2018, FDA issued a Form 483 with 4 observations to Baxter Oncology GmbH in Halle/Westfalen, Germany (FEI 3002806419) after an inspection that ran Jun 4 – Jun 14, 2018. The investigators were Emilie Kahn and Luis M. Burges. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
Equipment used in the manufacture, processing, packing, or holding of drug product is not of appropriate…
- 03
The batch production and control records are deficient in that they do not include documentation of…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Emilie Kahn
15 documents · 2016–2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Michigan.
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 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Baxter Oncology GmbH?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Baxter Oncology GmbH?
Emilie Kahn and Luis M. Burges are named on this Form 483, for the inspection of Jun 4 – Jun 14, 2018. Each investigator has a profile showing what they cite most.
When was Baxter Oncology GmbH inspected by FDA?
The inspection ran Jun 4 – Jun 14, 2018, and the Form 483 is dated June 14, 2018.
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.