FDA Inspection
Johns Hopkins Hospital Blood BankJohns Hopkins Hospital Blood Bank – FDA Inspection, Feb 13, 2025
Record Details
This FDA Inspection record concerns Johns Hopkins Hospital Blood Bank, with an inspection on February 13, 2025, issued by the Baltimore District Office, covering biologics.
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ID · b722b171-f380-4414-9ef8-11655a52b71b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1260819
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.151(e)Procedures to maintain records of emergency transfusions
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Johns Hopkins Hospital Blood Bank
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 23, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 14, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 27, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 26, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 3, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Johns Hopkins Hospital Blood Bank
- FDA Inspection 1167106 - 2022-03-23
- FDA Inspection 1020993 - 2017-07-14
- FDA Inspection 916474 - 2015-02-27
- FDA Inspection 851936 - 2013-09-26
- FDA Inspection 847385 - 2013-09-03
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