FDA Inspection
Lutheran Medical CenterLutheran Medical Center – FDA Inspection, Jan 13, 2012
Record Details
This FDA Inspection record concerns Lutheran Medical Center, with an inspection on January 13, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Lutheran Medical Center
- Inspection Date
- January 13, 2012
- Product Type
- Biologics
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ID · e6b22bc9-5042-471d-8bb2-c4d45f1a4c5c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 763005
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 606.40(a)(1)Provide space for examination
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 211.182Personnel dating/signing equipment log
- 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
- 21 CFR 606.100(b)(14)QC procedures for supplies and reagents
- 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 |
| April 1, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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