FDA Inspection
Shady Grove Reproductive Science Center PCShady Grove Reproductive Science Center PC – FDA Inspection, Oct 18, 2018
Record Details
This FDA Inspection record concerns Shady Grove Reproductive Science Center PC, with an inspection on October 18, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- October 18, 2018
- Product Type
- Biologics
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ID · d7456069-31f0-42e7-ae56-62f92736911c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1069377
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.50(b)(1)Donor screening standards
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Shady Grove Reproductive Science Center PC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 2, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 2, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 14, 2016 | Not classified | Baltimore District Office | |
| January 15, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 12, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Shady Grove Reproductive Science Center PC
- FDA Inspection 1246904 - 2024-07-02
- FDA Inspection 1173126 - 2022-06-02
- FDA Inspection 998177 - 2016-12-14
- FDA Inspection 910108 - 2015-01-15
- FDA Inspection 836603 - 2013-06-12
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