FDA Inspection
East Coast FertilityEast Coast Fertility – FDA Inspection, Jan 6, 2009
Record Details
This FDA Inspection record concerns East Coast Fertility, with an inspection on January 6, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- East Coast Fertility
- Inspection Date
- January 6, 2009
- Product Type
- Biologics
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ID · 47800095-35a0-4098-8af7-f72b34fceac8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 554961
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.75(c)Reproductive cells/ tissues- general
- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Procedures for all other requirements
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