FDA Inspection
Biomet TexasBiomet Texas – FDA Inspection, Jul 15, 2009
Record Details
This FDA Inspection record concerns Biomet Texas, with an inspection on July 15, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Biomet Texas
- Inspection Date
- July 15, 2009
- Product Type
- Biologics
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ID · 291ca767-7fa6-45b0-bfc5-134a9f6c91ac
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 598988
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.265(e)Documentation elements for activities
- 21 CFR 1271.270(d)Retention time (10 year rules)
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of Biomet Texas
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 31, 2010 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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