FDA Inspection 637937 — Excelsior Medical LLC
The FDA completed an inspection of Excelsior Medical LLC on January 8, 2010 in Neptune, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 8, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Neptune, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2429 | 21 CFR 820.30(b) | Establish the design and development plan |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |