FDA Inspection
Baptist Medical CenterBaptist Medical Center – FDA Inspection, Apr 3, 2009
Record Details
This FDA Inspection record concerns Baptist Medical Center, with an inspection on April 3, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Baptist Medical Center
- Inspection Date
- April 3, 2009
- Product Type
- Biologics
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ID · 1fd673b9-7878-43d7-9ba8-eedfbe4408b4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 573926
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.100(c)Record review prior to release
- 21 CFR 606.60(a)Provide proper equipment to meet requirements
- 21 CFR 606.140(c)Adequate identification and handling of test samples
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Baptist Medical Center
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 8, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 10, 2008 | OAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Baptist Medical Center
- FDA Inspection 743682 - 2011-09-08
- FDA Inspection 553241 - 2008-12-10
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