FDA Inspection
Sher Fertility Solutions New YorkSher Fertility Solutions New York – FDA Inspection, Aug 31, 2012
Record Details
This FDA Inspection record concerns Sher Fertility Solutions New York, with an inspection on August 31, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 31, 2012
- Product Type
- Biologics
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ID · 6d62b3bc-4d54-413f-a3f7-525257fec6a0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 796132
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
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Other FDA inspections of Sher Fertility Solutions New York
8| Date | Classification | Office | Project area |
|---|---|---|---|
| July 22, 2025 | Not classified | New York District Office | Human Cellular, Tissue, and Gene Therapies |
| March 20, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 1, 2022 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 10, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 22, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Sher Fertility Solutions New York
- FDA Inspection 1276229 - 2025-07-22
- FDA Inspection 1200777 - 2023-03-20
- FDA Inspection 1166207 - 2022-04-01
- FDA Inspection 1092693 - 2019-06-10
- FDA Inspection 996689 - 2016-12-22
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