FDA Inspection
Boston Medical Center CorporationBoston Medical Center Corporation – FDA Inspection, Mar 18, 2016
Record Details
This FDA Inspection record concerns Boston Medical Center Corporation, with an inspection on March 18, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 18, 2016
- Product Type
- Biologics
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ID · 81980f7e-039f-430d-b073-5bfd2811ebc3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 963517
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.60(a)Provide proper equipment to meet requirements
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Boston Medical Center Corporation
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 2, 2025 | Not classified | New England District Office | |
| September 12, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 16, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 3, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 27, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Boston Medical Center Corporation
- FDA Inspection 1270738 - 2025-05-02
- FDA Inspection 1218229 - 2023-09-12
- FDA Inspection 1091871 - 2019-05-16
- FDA Inspection 864614 - 2014-02-03
- FDA Inspection 759061 - 2011-12-27
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