FDA Inspection
Alabama Fertility Specialists, PCAlabama Fertility Specialists, PC – FDA Inspection, Mar 15, 2023
Record Details
This FDA Inspection record concerns Alabama Fertility Specialists, PC, with an inspection on March 15, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · e5f71869-c163-49d9-ba03-4db2b75d25af
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1199861
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
- 21 CFR 1271.55(b)(1)Statement re: certified testing lab
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
- 21 CFR 1271.55(b)(1)Statement re: certified testing lab
- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Alabama Fertility Specialists, PC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2025 | Not classified | New Orleans District Office | |
| August 22, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 4, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 19, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 25, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Alabama Fertility Specialists, PC
- FDA Inspection 1291262 - 2025-09-17
- FDA Inspection 1102301 - 2019-08-22
- FDA Inspection 1017589 - 2017-05-04
- FDA Inspection 904619 - 2014-11-19
- FDA Inspection 640198 - 2010-01-25
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