FDA Inspection
Baxter Oncology GmbHBaxter Oncology GmbH – FDA Inspection, Mar 18, 2016
Record Details
This FDA Inspection record concerns Baxter Oncology GmbH, with an inspection on March 18, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Baxter Oncology GmbH
- Inspection Date
- March 18, 2016
- Product Type
- Drugs
View Company Profile
ID · cee1839e-90d4-436f-a2f1-187376c7dc5a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 967376
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.28(b)Habits of good sanitation & health
- 21 CFR 211.42(b)Product flow through building is inadequate
- 21 CFR 211.192Written record of investigation incomplete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Baxter Oncology GmbH
11| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2025 | OAI | Office of Inspections and Investigations | Drug Quality Assurance |
| 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 |
Other documents for Baxter Oncology GmbH
- FDA Inspection 1283802 - 2025-09-26
- FDA Inspection 1249702 - 2024-08-27
- FDA Inspection 1206312 - 2023-05-03
- FDA Inspection 1161093 - 2020-01-29
- FDA Inspection 1106642 - 2019-09-03
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