FDA Inspection
Kofinas Fertility GroupFDA Inspection 606273 - Kofinas Fertility Group - August 19, 2009
Record Details
This FDA Inspection record concerns Kofinas Fertility Group, with an inspection on August 19, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Kofinas Fertility Group
- Inspection Date
- August 19, 2009
- Product Type
- Biologics
View Company Profile
ID · 604b2627-20ba-44f4-b389-8d0b44ae041b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 606273
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.75(e)Abbreviated procedure
- 21 CFR 1271.50(a)Responsible person to determine, document
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Kofinas Fertility Group
7| Date | Classification | Office | Project area |
|---|---|---|---|
| April 9, 2025 | VAI | New York District Office | Human Cellular, Tissue, and Gene Therapies |
| July 25, 2023 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 13, 2020 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 25, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 11, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Kofinas Fertility Group
- FDA Inspection 1266536 - 2025-04-09
- FDA Inspection 1210757 - 2023-07-25
- FDA Inspection 1122513 - 2020-02-13
- FDA Inspection 1056801 - 2018-06-25
- FDA Inspection 963390 - 2016-03-11
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.