FDA Inspection
Holyoke Medical Center Inc.Holyoke Medical Center Inc. – FDA Inspection, Dec 6, 2010
Record Details
This FDA Inspection record concerns Holyoke Medical Center Inc., with an inspection on December 6, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Holyoke Medical Center Inc.
- Inspection Date
- December 6, 2010
- Product Type
- Biologics
View Company Profile
ID · 275568fb-c569-4c4c-a6c7-5bfb1a360332
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 702369
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.100(b)(21)Donor notification
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Holyoke Medical Center Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 1, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 9, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| August 17, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 30, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 30, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Holyoke Medical Center Inc.
- FDA Inspection 1237775 - 2024-05-01
- FDA Inspection 1177784 - 2022-08-09
- FDA Inspection 1066944 - 2018-08-17
- FDA Inspection 966102 - 2016-03-30
- FDA Inspection 847191 - 2013-08-30
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