FDA Inspection
Pure Source LLCPure Source LLC – FDA Inspection, Sep 22, 2011
Record Details
This FDA Inspection record concerns Pure Source LLC, with an inspection on September 22, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Pure Source LLC
- Inspection Date
- September 22, 2011
- Product Type
- Drugs
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ID · d7c208e7-cb1a-4e11-b748-7327a8fa194e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 746108
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.188(b)(2)Identity of major equipment and lines used
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.165(c)Sampling and testing plans not described
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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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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