FDA Inspection
Newton-Wellesley HospitalNewton-Wellesley Hospital – FDA Inspection, Aug 12, 2010
Record Details
This FDA Inspection record concerns Newton-Wellesley Hospital, with an inspection on August 12, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Newton-Wellesley Hospital
- Inspection Date
- August 12, 2010
- Product Type
- Biologics
View Company Profile
ID · 63b5bcae-6b4e-4093-8fb0-cbd9f85fefec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 676502
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
1- 21 CFR 606.121(c)(13)Unapproved encoded/machine readable information
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Newton-Wellesley Hospital
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 29, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 2, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 31, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Newton-Wellesley Hospital
- FDA Inspection 1004473 - 2017-03-13
- FDA Inspection 966101 - 2016-03-29
- FDA Inspection 859322 - 2013-12-02
- FDA Inspection 784154 - 2012-05-31
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