FDA Inspection
JR Enterprizes of South Florida, Inc.JR Enterprizes of South Florida, Inc. – FDA Inspection, Jun 6, 2016
Record Details
This FDA Inspection record concerns JR Enterprizes of South Florida, Inc., with an inspection on June 6, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 6, 2016
- Product Type
- Biologics
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ID · b599d0b1-4998-4e94-baa7-0c9a0e002d99
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 980167
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
- 21 CFR 1271.200(c)Calibration procedures and schedules (general)
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Other FDA inspections of JR Enterprizes of South Florida, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 27, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 21, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for JR Enterprizes of South Florida, Inc.
- FDA Inspection 1087091 - 2019-03-27
- FDA Inspection 880448 - 2014-05-21
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