FDA Inspection 637139 — Healthbanks Biotech USA Inc
The FDA completed an inspection of Healthbanks Biotech USA Inc on January 15, 2010 in Irvine, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 15, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12311 | 21 CFR 1271.160(b)(1) | Ensuring appropriate core requirements followed |
| 12359 | 21 CFR 1271.195(a)(3) | Aseptic processing---cleaning, disinfecting |
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |
| 12408 | 21 CFR 1271.250(c) | All labeling requirements met |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |