FDA Inspection 1066677 — Liveyon
The FDA completed an inspection of Liveyon on Sep 21, 2018 in Yorba Linda, 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
- Sep 21, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Yorba Linda, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12239 | 21 CFR 1271.55(b)(2) | Listing and interpretation of CD tests performed |
| 12373 | 21 CFR 1271.200(d) | Inspected routinely |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12424 | 21 CFR 1271.265(c)(1) | Release criteria verified, documented |
| 12429 | 21 CFR 1271.265(d) | Shipping conditions appropriate |
| 12469 | 21 CFR 1271.350(a)(1) | Adverse reaction reporting to FDA |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |