FDA Inspection
Meriter Health EnterprisesMeriter Health Enterprises – FDA Inspection, May 7, 2025
Record Details
This FDA Inspection record concerns Meriter Health Enterprises, with an inspection on May 7, 2025, issued by the Minneapolis District Office, covering biologics.
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ID · 23598081-16d4-4ff4-ae79-e6425b8fa60d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1269353
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.140(a)Establishment of spec., standards, and test procedures
- 21 CFR 606.160(b)Required records
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Meriter Health Enterprises
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 10, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 31, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 18, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 12, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Meriter Health Enterprises
- FDA Inspection 1163537 - 2022-02-10
- FDA Inspection 1032127 - 2017-10-31
- FDA Inspection 952970 - 2015-12-18
- FDA Inspection 854855 - 2013-11-12
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