FDA Inspection 823145 — Rocky Mountain Tissue Bank
The FDA completed an inspection of Rocky Mountain Tissue Bank on Feb 22, 2013 in Aurora, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 14 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 22, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Aurora, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12325 | 21 CFR 1271.160(b)(6) | Deviations--evaluation, cause, corrective action |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12342 | 21 CFR 1271.190(a) | Size, construction, location--prevent mix-ups etc. |
| 12344 | 21 CFR 1271.190(a) | Lighting, ventilation, plumbing |
| 12351 | 21 CFR 1271.190(d)(1) | Procedures for cleaning, sanitation |
| 12356 | 21 CFR 1271.195(a) | Adequate control, proper conditions |
| 12357 | 21 CFR 1271.195(a)(1) | Temperature and humidity controls |
| 12359 | 21 CFR 1271.195(a)(3) | Aseptic processing---cleaning, disinfecting |
| 12362 | 21 CFR 1271.195(b) | Corrective actions |
| 12363 | 21 CFR 1271.195(c) | Monitoring--cross contamination, exposure to CD |
| 12391 | 21 CFR 1271.220(c) | Sampling representative (in-process HCT/Ps) |
| 12395 | 21 CFR 1271.225 | Verification/validation |
| 12426 | 21 CFR 1271.265(c)(2) | Improperly released for distribution |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |