FDA Inspection 747120 — Extremity Medical, LLC
The FDA completed an inspection of Extremity Medical, LLC on October 24, 2011 in Parsippany, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 24, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Parsippany, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 4192 | 21 CFR 806.10(a)(2) | Report of violation of the Act (see 803.52(e)(9)) |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |