FDA Inspection 847750 — SDI Diagnostics, Inc.
The FDA completed an inspection of SDI Diagnostics, Inc. on September 10, 2013 in South Easton, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 10, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- South Easton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |