FDA Inspection 905835 — New World Medical Inc
The FDA completed an inspection of New World Medical Inc on December 4, 2014 in Rancho Cucamonga, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- December 4, 2014
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Rancho Cucamonga, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |