FDA Inspection
Newark Beth Israel Medical Center - Blood BankNewark Beth Israel Medical Center - Blood Bank – FDA Inspection, Oct 13, 2023
Record Details
This FDA Inspection record concerns Newark Beth Israel Medical Center - Blood Bank, with an inspection on October 13, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- October 13, 2023
- Product Type
- Biologics
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ID · 979cfab4-e792-4caf-8cba-bb9d65675f15
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1220208
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
- 21 CFR 606.160(a)(1)Concurrent documentation
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Other FDA inspections of Newark Beth Israel Medical Center - Blood Bank
8| Date | Classification | Office | Project area |
|---|---|---|---|
| April 22, 2026 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 26, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| July 26, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 22, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 15, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Newark Beth Israel Medical Center - Blood Bank
- FDA Inspection 1314854 - 2026-04-22
- FDA Inspection 1168186 - 2022-04-26
- FDA Inspection 1061410 - 2018-07-26
- FDA Inspection 989086 - 2016-09-22
- FDA Inspection 887560 - 2014-07-15
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