FDA Inspection
Methodist Medical Center of IllinoisMethodist Medical Center of Illinois – FDA Inspection, Feb 17, 2011
Record Details
This FDA Inspection record concerns Methodist Medical Center of Illinois, with an inspection on February 17, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 17, 2011
- Product Type
- Biologics
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ID · c070ddca-0ecd-49a0-bbae-7ee6662a5be0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 707513
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
7- 21 CFR 606.100(c)Record review prior to release
- 21 CFR 606.160(b)Required records
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.151(e)Procedures to maintain records of emergency transfusions
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Methodist Medical Center of Illinois
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 18, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 21, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 6, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 4, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 18, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Methodist Medical Center of Illinois
- FDA Inspection 1174914 - 2022-07-18
- FDA Inspection 1052711 - 2018-03-21
- FDA Inspection 968485 - 2016-04-06
- FDA Inspection 873275 - 2014-04-04
- FDA Inspection 777434 - 2012-04-18
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