FDA Inspection
Muasher Center for Fertility and IVF, dba Partners for Fert.Muasher Center for Fertility and IVF, dba Partners for Fert. – FDA Inspection, Nov 5, 2014
Record Details
This FDA Inspection record concerns Muasher Center for Fertility and IVF, dba Partners for Fert., with an inspection on November 5, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 5, 2014
- Product Type
- Biologics
View Company Profile
ID · 75042086-e3dd-43f1-99c9-043fe1278826
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 904408
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 1271.55(a)(2)Eligibility statement--basis of determination
- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
- 21 CFR 1271.80(c)Kits not FDA approved, specifically labeled
- 21 CFR 1271.75(c)Reproductive cells/ tissues- general
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.55(b)(1)Statement re: certified testing lab
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Muasher Center for Fertility and IVF, dba Partners for Fert.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 8, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 14, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Muasher Center for Fertility and IVF, dba Partners for Fert.
- FDA Inspection 818218 - 2013-02-08
- FDA Inspection 659043 - 2010-04-14
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.