FDA Inspection 681855 — Kat Implants, LLC
The FDA completed an inspection of Kat Implants, LLC on August 30, 2010 in Portsmouth, NH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 30, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Portsmouth, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |