FDA Inspection
Parker-Roseman-Rodi Gynocology Infertility Medical GroupParker-Roseman-Rodi Gynocology Infertility Medical Group – FDA Inspection, Sep 24, 2009
Record Details
This FDA Inspection record concerns Parker-Roseman-Rodi Gynocology Infertility Medical Group, with an inspection on September 24, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 24, 2009
- Product Type
- Biologics
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ID · 59d1d5e3-81c5-4dc4-b3f5-7da8ec2ef1b5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 613786
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.55(b)(1)Statement re: certified testing lab
- 21 CFR 1271.55(b)(3)Name and address on summary
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Other FDA inspections of Parker-Roseman-Rodi Gynocology Infertility Medical Group
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 25, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Parker-Roseman-Rodi Gynocology Infertility Medical Group
- FDA Inspection 742302 - 2011-08-25
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