FDA Inspection
Rocky Mountain Lions Eye BankRocky Mountain Lions Eye Bank – FDA Inspection, Feb 3, 2009
Record Details
This FDA Inspection record concerns Rocky Mountain Lions Eye Bank, with an inspection on February 3, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 3, 2009
- Product Type
- Biologics
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ID · 22f2ae7f-5500-408e-986f-4f21a20fc843
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 563285
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.265(d)Shipping conditions appropriate
- 21 CFR 1271.195(c)Monitoring--cross contamination, exposure to CD
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.210(a)Use prior to verification
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Other FDA inspections of Rocky Mountain Lions Eye Bank
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 27, 2024 | VAI | Denver District Office | Blood and Blood Products |
| April 26, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 21, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 16, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 12, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Rocky Mountain Lions Eye Bank
- FDA Inspection 1250468 - 2024-09-27
- FDA Inspection 1057040 - 2018-04-26
- FDA Inspection 951842 - 2015-08-21
- FDA Inspection 769336 - 2012-02-16
- FDA Inspection 676302 - 2010-08-12
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