FDA Inspection
Reproductive Endocrine Center Sperm Physiology LabReproductive Endocrine Center Sperm Physiology Lab – FDA Inspection, May 31, 2018
Record Details
This FDA Inspection record concerns Reproductive Endocrine Center Sperm Physiology Lab, with an inspection on May 31, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 31, 2018
- Product Type
- Biologics
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ID · fdd45299-8773-424d-b1cd-82edef7209a9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1054339
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.85(a)Infection with communicable disease agents
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Other FDA inspections of Reproductive Endocrine Center Sperm Physiology Lab
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 8, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 24, 2021 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 25, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 22, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 12, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Reproductive Endocrine Center Sperm Physiology Lab
- FDA Inspection 1207942 - 2023-06-08
- FDA Inspection 1137606 - 2021-03-24
- FDA Inspection 989225 - 2016-10-25
- FDA Inspection 900960 - 2014-10-22
- FDA Inspection 811070 - 2012-12-12
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