FDA Inspection
Pure Source LLCPure Source LLC – FDA Inspection, Jun 23, 2017
Record Details
This FDA Inspection record concerns Pure Source LLC, with an inspection on June 23, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- People
- Alexander B. Anderson (Issuing Officer)
- Jorge L. Lajara (Issuing Officer)
- Lissette Paiz (Company Rep)
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ID · 955ba4fe-f3fe-445b-bd5c-8dbd347fbd2d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1015800
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 111.12Personnel - quality control personnel - qualified
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(e)Specifications - contamination limits
- 21 CFR 111.27(d)Equipment - maintain - general
- 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
- 21 CFR 111.20(f)Physical plant - bulbs, fixtures, skylights
- 21 CFR 111.75(c)Specifications met - verify; finished batch
- 21 CFR 111.20(d)(1)(i)Floors, walls, ceilings
- 21 CFR 111.20(b)Physical plant - space; equipment, materials
- 21 CFR 111.20(d)(1)(iv)Physical plant - temperature, humidity controls
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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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