FDA Inspection
Surgi-Care, Inc.Surgi-Care, Inc. – FDA Inspection, Jan 14, 2009
Record Details
This FDA Inspection record concerns Surgi-Care, Inc., with an inspection on January 14, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Surgi-Care, Inc.
- Inspection Date
- January 14, 2009
- Product Type
- Biologics
View Company Profile
ID · f3464e51-ad37-4fa8-bad6-06fd52008f60
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 638764
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 1271.270(a)Accurate, indelible, legible
- 21 CFR 1271.160(b)(1)Ensuring appropriate core requirements followed
- 21 CFR 1271.160(b)(4)Training of personnel
- 21 CFR 1271.160(b)(5)Monitoring systems
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Other FDA inspections of Surgi-Care, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 10, 2020 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 12, 2017 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 10, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 11, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Surgi-Care, Inc.
- FDA Inspection 1120374 - 2020-02-10
- FDA Inspection 997637 - 2017-01-12
- FDA Inspection 920502 - 2015-03-10
- FDA Inspection 828785 - 2013-04-11
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