FDA Inspection
Family Beginnings, PCFamily Beginnings, PC – FDA Inspection, Nov 20, 2023
Record Details
This FDA Inspection record concerns Family Beginnings, PC, with an inspection on November 20, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 5b3af251-4813-4c9a-b457-03be53b9bdca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1223083
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.85(a)Infection with communicable disease agents
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Family Beginnings, PC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 8, 2020 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 8, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 13, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 25, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 8, 2012 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Family Beginnings, PC
- FDA Inspection 1116738 - 2020-01-08
- FDA Inspection 1013273 - 2017-06-08
- FDA Inspection 918162 - 2015-03-13
- FDA Inspection 805303 - 2012-10-25
- FDA Inspection 781227 - 2012-05-08
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