FDA Inspection
NIH Donor Center at Fishers LaneNIH Donor Center at Fishers Lane – FDA Inspection, Jul 11, 2019
Record Details
This FDA Inspection record concerns NIH Donor Center at Fishers Lane, with an inspection on July 11, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 9b134125-4c6b-4a0b-9064-6bcf29d18b17
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1096052
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 640.21(g)Informed consent
- 21 CFR 630.10(g)(1)Proof Of Identity
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of NIH Donor Center at Fishers Lane
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2025 | Not classified | Baltimore District Office | |
| July 26, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 17, 2017 | Not classified | Baltimore District Office | Blood and Blood Products |
Other documents for NIH Donor Center at Fishers Lane
- FDA Inspection 1263747 - 2025-03-06
- FDA Inspection 1215669 - 2023-07-26
- FDA Inspection 1010300 - 2017-04-17
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