FDA Inspection 944001 — Davis Schottlander and Davis, Ltd.
The FDA completed an inspection of Davis Schottlander and Davis, Ltd. on September 24, 2015 in Letchworth Garden City. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 24, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Letchworth Garden City (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |