FDA Inspection
Montgomery Fertility CenterMontgomery Fertility Center – FDA Inspection, Jan 21, 2020
Record Details
This FDA Inspection record concerns Montgomery Fertility Center, with an inspection on January 21, 2020, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Montgomery Fertility Center
- Inspection Date
- January 21, 2020
- Product Type
- Biologics
View Company Profile
ID · e0680b57-3f45-4aa0-8f16-5d9963dc7977
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1115747
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 1271.55(a)(2)Eligibility statement--basis of determination
- 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
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Other FDA inspections of Montgomery Fertility Center
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 17, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 28, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 11, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| December 20, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 1, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Montgomery Fertility Center
- FDA Inspection 1228628 - 2024-01-17
- FDA Inspection 1178714 - 2022-07-28
- FDA Inspection 1148840 - 2021-08-11
- FDA Inspection 1037445 - 2017-12-20
- FDA Inspection 979465 - 2016-08-01
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