FDA Inspection 980678 — Sterling Diagnostics, Inc.
The FDA completed an inspection of Sterling Diagnostics, Inc. on July 28, 2016 in Sterling Heights, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 28, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sterling Heights, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |