FDA Inspection
Methodist Hospitals, Inc.Methodist Hospitals, Inc. – FDA Inspection, Apr 12, 2017
Record Details
This FDA Inspection record concerns Methodist Hospitals, Inc., with an inspection on April 12, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · f40ab246-4b83-45b5-8dea-84b95bbb5417
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1009902
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Methodist Hospitals, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2024 | Not classified | Detroit District Office | |
| March 21, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 16, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Methodist Hospitals, Inc.
- FDA Inspection 1251353 - 2024-09-16
- FDA Inspection 1089683 - 2019-03-21
- FDA Inspection 950345 - 2015-10-16
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