FDA Inspection
New England Donor ServicesNew England Donor Services – FDA Inspection, Aug 1, 2013
Record Details
This FDA Inspection record concerns New England Donor Services, with an inspection on August 1, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- New England Donor Services
- Inspection Date
- August 1, 2013
- Product Type
- Biologics
View Company Profile
ID · ba33b7c5-c17a-454a-afef-7f80c35f03f4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 844021
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.195(a)(3)Aseptic processing---cleaning, disinfecting
- 21 CFR 1271.190(d)(1)Procedures for cleaning, sanitation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of New England Donor Services
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 28, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 22, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 25, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 15, 2010 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for New England Donor Services
- FDA Inspection 1261185 - 2025-01-28
- FDA Inspection 1088409 - 2019-03-22
- FDA Inspection 983543 - 2016-08-25
- FDA Inspection 696247 - 2010-10-15
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