FDA Inspection 1090488 — Liveyon Labs Inc
The FDA completed an inspection of Liveyon Labs Inc on May 23, 2019 in Yorba Linda, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 23, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Yorba Linda, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |