FDA Inspection
Baxter Pharmaceutical Solutions, LLCBaxter Pharmaceutical Solutions, LLC – FDA Inspection, May 10, 2013
Record Details
This FDA Inspection record concerns Baxter Pharmaceutical Solutions, LLC, with an inspection on May 10, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 10, 2013
- Product Type
- Drugs
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ID · f561ecc7-6269-4399-82f0-b1a2264a49dd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 831076
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.84(d)(3)Certificates of Testing (Containers, Closures)
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Baxter Pharmaceutical Solutions, LLC
19| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2025 | Not classified | Detroit District Office | Blood and Blood Products |
| September 24, 2024 | Not classified | Detroit District Office | |
| July 26, 2024 | Not classified | Detroit District Office | |
| February 20, 2024 | Not classified | Detroit District Office | |
| February 17, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Baxter Pharmaceutical Solutions, LLC
- FDA Inspection 1290838 - 2025-12-11
- FDA Inspection 1242468 - 2024-09-24
- FDA Inspection 1243512 - 2024-07-26
- FDA Inspection 1230675 - 2024-02-20
- FDA Inspection 1200813 - 2023-02-17
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