FDA Inspection
Cooper Institute for Reproductive Hormonal Disorders, P.C.Cooper Institute for Reproductive Hormonal Disorders, P.C. – FDA Inspection, May 6, 2010
Record Details
This FDA Inspection record concerns Cooper Institute for Reproductive Hormonal Disorders, P.C., with an inspection on May 6, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 6, 2010
- Product Type
- Biologics
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ID · 2375ea2a-9591-44ae-b48c-46278fb4fa94
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 662101
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.50(b)(1)Donor screening standards
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cooper Institute for Reproductive Hormonal Disorders, P.C.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 9, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 1, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 31, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 10, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 27, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Cooper Institute for Reproductive Hormonal Disorders, P.C.
- FDA Inspection 1244990 - 2024-07-09
- FDA Inspection 1167728 - 2022-04-01
- FDA Inspection 1054887 - 2018-05-31
- FDA Inspection 961504 - 2016-02-10
- FDA Inspection 868830 - 2014-02-27
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