FDA Inspection 1052281 — Orbbo Biotechnology LLC
The FDA completed an inspection of Orbbo Biotechnology LLC on May 2, 2018 in Los Angeles, CA. 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). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 2, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Los Angeles, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12310 | 21 CFR 1271.160(a) | All core requirements covered in program |
| 12351 | 21 CFR 1271.190(d)(1) | Procedures for cleaning, sanitation |
| 12372 | 21 CFR 1271.200(c) | Calibrated per established schedules |
| 12417 | 21 CFR 1271.260(e) | Periodic review of temperatures |
| 12421 | 21 CFR 1271.265(a) | Acceptance criteria designed to prevent CD |
| 12432 | 21 CFR 1271.265(e) | Documentation elements for activities |
| 12447 | 21 CFR 1271.290(b) | Establishing a system |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |