FDA Inspection
Baxter Oncology GmbHBaxter Oncology GmbH – FDA Inspection, Sep 26, 2025
Record Details
This FDA Inspection record concerns Baxter Oncology GmbH, with an inspection on September 26, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · d2cc3497-33d6-41da-be71-fed681081e29
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1283802
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Baxter Oncology GmbH
11| Date | Classification | Office | Project area |
|---|---|---|---|
| August 27, 2024 | Not classified | Office of Inspections and Investigations | |
| May 3, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 29, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 3, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 14, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Baxter Oncology GmbH
- FDA Inspection 1249702 - 2024-08-27
- FDA Inspection 1206312 - 2023-05-03
- FDA Inspection 1161093 - 2020-01-29
- FDA Inspection 1106642 - 2019-09-03
- FDA Inspection 1056958 - 2018-06-14
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