FDA Inspection 883926 — LockDown Medical Ltd.
The FDA completed an inspection of LockDown Medical Ltd. on June 5, 2014 in Redditch. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 5, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Redditch (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |