FDA Inspection
NIH Clinical CenterNIH Clinical Center – FDA Inspection, Apr 23, 2013
Record Details
This FDA Inspection record concerns NIH Clinical Center, with an inspection on April 23, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- NIH Clinical Center
- Inspection Date
- April 23, 2013
- Product Type
- Biologics
View Company Profile
ID · 741540b7-7bd9-4b49-a68a-f2951e483376
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 838653
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 630.40(c)Notification w/in 8 weeks
- 21 CFR 606.171Biological product deviation report
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of NIH Clinical Center
7| Date | Classification | Office | Project area |
|---|---|---|---|
| January 21, 2025 | Not classified | Baltimore District Office | |
| December 1, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| August 31, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 15, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 11, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for NIH Clinical Center
- FDA Inspection 1259572 - 2025-01-21
- FDA Inspection 1160826 - 2021-12-01
- FDA Inspection 1040752 - 2017-08-31
- FDA Inspection 988673 - 2016-08-15
- FDA Inspection 914710 - 2015-02-11
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