FDA Inspection
Saddleback Memorial Medical CenterSaddleback Memorial Medical Center – FDA Inspection, Apr 1, 2010
Record Details
This FDA Inspection record concerns Saddleback Memorial Medical Center, with an inspection on April 1, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 1, 2010
- Product Type
- Biologics
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ID · e312601f-139c-4e95-ae02-7d80471c12bf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 655044
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.160(a)(2)Determination of lot numbers and supplies
- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Saddleback Memorial Medical Center
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 6, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 10, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 31, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 26, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Saddleback Memorial Medical Center
- FDA Inspection 1242278 - 2024-06-06
- FDA Inspection 1080943 - 2019-02-06
- FDA Inspection 1004449 - 2017-01-10
- FDA Inspection 940284 - 2015-08-31
- FDA Inspection 838125 - 2013-06-26
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