FDA Inspection
Maimonides Medical CenterMaimonides Medical Center – FDA Inspection, Oct 21, 2010
Record Details
This FDA Inspection record concerns Maimonides Medical Center, with an inspection on October 21, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Maimonides Medical Center
- Inspection Date
- October 21, 2010
- Product Type
- Biologics
View Company Profile
ID · 98f9a02b-c12f-481e-9040-66c0c9c65809
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 685252
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Maimonides Medical Center
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 15, 2024 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 20, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 4, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 21, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 24, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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