FDA Inspection 671040 — Intra-Lock International Inc.
The FDA completed an inspection of Intra-Lock International Inc. on July 2, 2010 in Birminghma, AL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 2, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Birminghma, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |