FDA Inspection
Sunrise Medical Laboratories, Inc.Sunrise Medical Laboratories, Inc. – FDA Inspection, Nov 19, 2010
Record Details
This FDA Inspection record concerns Sunrise Medical Laboratories, Inc., with an inspection on November 19, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 19, 2010
- Product Type
- Biologics
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ID · 2e7b46e3-b9c7-4954-8779-22397016e5be
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 698855
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.270(a)Records maintained concurrently
- 21 CFR 1271.80(c)Manufacturer instructions not followed
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Other FDA inspections of Sunrise Medical Laboratories, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 14, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 15, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Sunrise Medical Laboratories, Inc.
- FDA Inspection 900341 - 2014-10-14
- FDA Inspection 807126 - 2012-11-15
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