FDA Inspection
New England Cryogenic Center, Inc.New England Cryogenic Center, Inc. – FDA Inspection, Mar 6, 2012
Record Details
This FDA Inspection record concerns New England Cryogenic Center, Inc., with an inspection on March 6, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 6, 2012
- Product Type
- Biologics
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ID · 70aad763-1d6c-4982-bb22-c0c4b90011ee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 767433
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.160(b)(6)Deviations--Investigation, documenting, trending
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of New England Cryogenic Center, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| August 13, 2025 | Not classified | New England District Office | |
| November 3, 2021 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 5, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 7, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 10, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for New England Cryogenic Center, Inc.
- FDA Inspection 1281063 - 2025-08-13
- FDA Inspection 1158602 - 2021-11-03
- FDA Inspection 1074514 - 2018-11-05
- FDA Inspection 994774 - 2016-12-07
- FDA Inspection 895389 - 2014-09-10
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