FDA Inspection
UMASS Memorial Medical Center, Inc.UMASS Memorial Medical Center, Inc. – FDA Inspection, Sep 2, 2009
Record Details
This FDA Inspection record concerns UMASS Memorial Medical Center, Inc., with an inspection on September 2, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 2, 2009
- Product Type
- Biologics
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ID · 69be45a2-9aef-4626-a063-4bf2adf1a623
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 613229
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.100(c)Record review prior to release
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of UMASS Memorial Medical Center, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| December 10, 2024 | Not classified | New England District Office | |
| August 23, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| September 28, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 10, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 1, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for UMASS Memorial Medical Center, Inc.
- FDA Inspection 1257466 - 2024-12-10
- FDA Inspection 1179829 - 2022-08-23
- FDA Inspection 1069129 - 2018-09-28
- FDA Inspection 952727 - 2015-12-10
- FDA Inspection 876776 - 2014-05-01
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