FDA Inspection
Durbin & Associates, Inc.Durbin & Associates, Inc. – FDA Inspection, Nov 19, 2009
Record Details
This FDA Inspection record concerns Durbin & Associates, Inc., with an inspection on November 19, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Durbin & Associates, Inc.
- Inspection Date
- November 19, 2009
- Product Type
- Biologics
View Company Profile
ID · c2e5d71b-f479-4b19-9705-0a13ed6157c2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 631015
- 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 1271.160(a)Program is appropriate for the HCT/Ps
- 21 CFR 1270.33(a)Accurate, indelible, legible
- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.160(d)Validation for intended use
- 21 CFR 1271.200(c)Calibration procedures and schedules (general)
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