FDA Inspection
Surgical Biologics, IncSurgical Biologics, Inc – FDA Inspection, Aug 9, 2012
Record Details
This FDA Inspection record concerns Surgical Biologics, Inc, with an inspection on August 9, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Surgical Biologics, Inc
- Inspection Date
- August 9, 2012
- Product Type
- Biologics
View Company Profile
ID · 0af1ec20-efc2-4055-8d89-6b9a164b14b1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 808038
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.260(d)Corrective actions
- 21 CFR 1271.160(b)(3)Problem description, disposition, date et. al.
- 21 CFR 1271.190(b)(1)Clean, sanitary, orderly manner
- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
- 21 CFR 1271.160(b)(4)Training of personnel
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Other FDA inspections of Surgical Biologics, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Surgical Biologics, Inc
- FDA Inspection 896803 - 2014-09-17
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