FDA Inspection 1035513 — Sterling Diagnostics, Inc.
The FDA completed an inspection of Sterling Diagnostics, Inc. on December 20, 2017 in Sterling Heights, MI. 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
- December 20, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Sterling Heights, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |