FDA Inspection 696611 — Lifebanc
The FDA completed an inspection of Lifebanc on November 2, 2010 in Warrensville Heights, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 2, 2010
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Warrensville Heights, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |
| 12311 | 21 CFR 1271.160(b)(1) | Ensuring appropriate core requirements followed |
| 12325 | 21 CFR 1271.160(b)(6) | Deviations--evaluation, cause, corrective action |