FDA Inspection
Alta Bates IVF ProgramAlta Bates IVF Program – FDA Inspection, Dec 2, 2011
Record Details
This FDA Inspection record concerns Alta Bates IVF Program, with an inspection on December 2, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Alta Bates IVF Program
- Inspection Date
- December 2, 2011
- Product Type
- Biologics
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ID · b9fc4c9f-e2e1-4cc7-b7b9-173f6511ab30
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 755483
- 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(d)Donors with risks not determined ineligible
- 21 CFR 1271.65(a)Improper release prevention--storage, I.D.
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.55(b)(2)Listing and interpretation of CD tests performed
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Other FDA inspections of Alta Bates IVF Program
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 22, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Alta Bates IVF Program
- FDA Inspection 1023187 - 2017-07-17
- FDA Inspection 878546 - 2014-05-22
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