FDA Inspection
Surgical Innovations CorpSurgical Innovations Corp – FDA Inspection, Jul 27, 2016
Record Details
This FDA Inspection record concerns Surgical Innovations Corp, with an inspection on July 27, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Surgical Innovations Corp
- Inspection Date
- July 27, 2016
- Product Type
- Biologics
View Company Profile
ID · b6b53b09-581e-4b00-a009-1a81b667694c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 989056
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 1271.270(a)Records incomplete
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of Surgical Innovations Corp
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 24, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 11, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Surgical Innovations Corp
- FDA Inspection 1221404 - 2023-10-24
- FDA Inspection 1087598 - 2019-04-11
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