FDA Inspection 821624 — LiveOnNY
The FDA completed an inspection of LiveOnNY on March 15, 2013 in Long Island City, NY. 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
- March 15, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Long Island City, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12326 | 21 CFR 1271.160(c) | Quality audits performed periodically |
| 12334 | 21 CFR 1271.170(c) | Trained or re-trained as necessary |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12436 | 21 CFR 1271.270(a) | Accurate, indelible, legible |