FDA Inspection
JDA Surgical Associates, IncJDA Surgical Associates, Inc – FDA Inspection, Dec 9, 2009
Record Details
This FDA Inspection record concerns JDA Surgical Associates, Inc, with an inspection on December 9, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- JDA Surgical Associates, Inc
- Inspection Date
- December 9, 2009
- Product Type
- Biologics
View Company Profile
ID · 3eda9c1a-656b-4189-8d74-1797401750c1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 634635
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 1271.290(e)Documenting disposition of each HCT/P
- 21 CFR 1271.260(d)Corrective actions
- 21 CFR 1271.170(c)Trained or re-trained as necessary
- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 1270.35(c)Receipt and/or distribution
- 21 CFR 1271.270(a)Records maintained concurrently
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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