FDA Inspection
Fertility Center of Orange County, A Medical Group Inc.Fertility Center of Orange County, A Medical Group Inc. – FDA Inspection, Aug 29, 2023
Record Details
This FDA Inspection record concerns Fertility Center of Orange County, A Medical Group Inc., with an inspection on August 29, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 29, 2023
- Product Type
- Biologics
View Company Profile
ID · 04e02e20-9f9f-4010-b133-69b785247e4f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1216494
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fertility Center of Orange County, A Medical Group Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 23, 2025 | Not classified | Los Angeles District Office | |
| November 7, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 15, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 30, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 20, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Fertility Center of Orange County, A Medical Group Inc.
- FDA Inspection 1262198 - 2025-01-23
- FDA Inspection 1033843 - 2017-11-07
- FDA Inspection 982623 - 2016-01-15
- FDA Inspection 845568 - 2013-07-30
- FDA Inspection 735249 - 2011-07-20
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.