FDA Inspection
Manhattan Reproductive Medicine, PCManhattan Reproductive Medicine, PC – FDA Inspection, Dec 21, 2017
Record Details
This FDA Inspection record concerns Manhattan Reproductive Medicine, PC, with an inspection on December 21, 2017, issued by the New York District Office, covering biologics.
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ID · 76c729a6-4e2b-4a04-a28c-0847fd544efa
Inspection Facts
- Inspection number
- 1035827
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.50(b)(1)Donor screening standards
- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.85(a)Infection with communicable disease agents
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Other FDA inspections of Manhattan Reproductive Medicine, PC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 24, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 29, 2022 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 12, 2020 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 18, 2014 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 31, 2013 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Manhattan Reproductive Medicine, PC
- FDA Inspection 1240497 - 2024-05-24
- FDA Inspection 1173216 - 2022-06-29
- FDA Inspection 1117589 - 2020-02-12
- FDA Inspection 895464 - 2014-09-18
- FDA Inspection 842598 - 2013-07-31
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