FDA Inspection
Rocky Mountain Tissue BankRocky Mountain Tissue Bank – FDA Inspection, Feb 22, 2013
Record Details
This FDA Inspection record concerns Rocky Mountain Tissue Bank, with an inspection on February 22, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Rocky Mountain Tissue Bank
- Inspection Date
- February 22, 2013
- Product Type
- Biologics
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ID · 5fd402d9-4ea8-4b72-8d98-97537920f14a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 823145
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
14- 21 CFR 1271.195(b)Corrective actions
- 21 CFR 1271.195(c)Monitoring--cross contamination, exposure to CD
- 21 CFR 1271.195(a)Adequate control, proper conditions
- 21 CFR 1271.195(a)(3)Aseptic processing---cleaning, disinfecting
- 21 CFR 1271.195(a)(1)Temperature and humidity controls
- 21 CFR 1271.190(a)Lighting, ventilation, plumbing
- 21 CFR 1271.190(a)Size, construction, location--prevent mix-ups etc.
- 21 CFR 1271.265(c)(2)Improperly released for distribution
- 21 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
- 21 CFR 1271.180(a)Procedures to meet core CTGP
Showing 10 of 14 citations.
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Other FDA inspections of Rocky Mountain Tissue Bank
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 4, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 17, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 24, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 22, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 15, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Rocky Mountain Tissue Bank
- FDA Inspection 1233237 - 2024-03-04
- FDA Inspection 1071051 - 2018-10-17
- FDA Inspection 997992 - 2016-10-24
- FDA Inspection 900994 - 2014-10-22
- FDA Inspection 709950 - 2011-02-15
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