FDA Inspection
DCI LaboratoryDCI Laboratory – FDA Inspection, Mar 15, 2013
Record Details
This FDA Inspection record concerns DCI Laboratory, with an inspection on March 15, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- DCI Laboratory
- Inspection Date
- March 15, 2013
- Product Type
- Biologics
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ID · c9e9a36b-1399-4247-ae05-2eb195711062
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 831845
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.170(c)Trained or re-trained as necessary
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.270(a)Accurate, indelible, legible
- 21 CFR 1271.200(c)Calibration procedures and schedules (general)
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Other FDA inspections of DCI Laboratory
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 11, 2010 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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