FDA Inspection
NIH Donor Center at Fishers LaneNIH Donor Center at Fishers Lane – FDA Inspection, Apr 17, 2017
Record Details
This FDA Inspection record concerns NIH Donor Center at Fishers Lane, with an inspection on April 17, 2017, issued by the Baltimore District Office, covering biologics.
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ID · 74ac3b08-a138-4d19-bedb-ef66d26ef43d
Inspection Facts
- Inspection number
- 1010300
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
- 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
- 21 CFR 606.40(d)(1)Provide adequate disposal of trash & discarded items
- 21 CFR 630.10(f)(6)(ii)Physical Assessment Determination - Skin Examination
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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 |
| July 11, 2019 | VAI | Center for Biologics Evaluation and Research | 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 1096052 - 2019-07-11
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