FDA Inspection
Cook Children's Medical Center (CCMC)Cook Children's Medical Center (CCMC) – FDA Inspection, Sep 27, 2012
Record Details
This FDA Inspection record concerns Cook Children's Medical Center (CCMC), with an inspection on September 27, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 27, 2012
- Product Type
- Biologics
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ID · 03e602f4-05ae-4097-8b18-ebd02a43d85f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 800812
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Cook Children's Medical Center (CCMC)
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 8, 2025 | Not classified | Dallas District Office | |
| February 28, 2020 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| February 15, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 1, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 9, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Cook Children's Medical Center (CCMC)
- FDA Inspection 1258391 - 2025-01-08
- FDA Inspection 1121119 - 2020-02-28
- FDA Inspection 1050595 - 2018-02-15
- FDA Inspection 963417 - 2016-03-01
- FDA Inspection 882366 - 2014-06-09
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