FDA Inspection 859085 — Sterling Diagnostics, Inc.
The FDA completed an inspection of Sterling Diagnostics, Inc. on December 16, 2013 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 16, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Sterling Heights, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3224 | 21 CFR 820.70(g)(2) | Periodic equipment inspection lack of or inadequate procedu |
| 4208 | 21 CFR 806.20(a) | Records not kept |