FDA Inspection
Lutheran Medical CenterLutheran Medical Center – FDA Inspection, Apr 1, 2010
Record Details
This FDA Inspection record concerns Lutheran Medical Center, with an inspection on April 1, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Lutheran Medical Center
- Inspection Date
- April 1, 2010
- Product Type
- Biologics
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ID · c64dcff3-0860-4b7c-a5ce-c912fb313caa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 653267
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Lutheran Medical Center
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 27, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 13, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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