FDA Inspection
Baxter Pharmaceutical Solutions, LLCBaxter Pharmaceutical Solutions, LLC – FDA Inspection, Jul 17, 2017
Record Details
This FDA Inspection record concerns Baxter Pharmaceutical Solutions, LLC, with an inspection on July 17, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 4892691b-652a-49f3-8669-5459d493badb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1019766
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.113(b)Validation lacking for sterile drug products
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Other FDA inspections of Baxter Pharmaceutical Solutions, LLC
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| 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
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- FDA Inspection 1243512 - 2024-07-26
- FDA Inspection 1230675 - 2024-02-20
- FDA Inspection 1200813 - 2023-02-17
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