FDA Inspection
Pure Source LLCPure Source LLC – FDA Inspection, Feb 24, 2014
Record Details
This FDA Inspection record concerns Pure Source LLC, with an inspection on February 24, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Pure Source LLC
- Inspection Date
- February 24, 2014
- Product Type
- Drugs
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ID · fe0c96b4-db5e-49d2-9531-d249f24d35b8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 867644
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 111.70(a)Specifications - manufacturing process
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Other FDA inspections of Pure Source LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| July 28, 2026 | NAI | Florida District Office | Postmarket Assurance: Devices |
| October 21, 2025 | Not classified | Florida District Office | Drug Quality Assurance |
| August 31, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 14, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 1, 2018 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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