FDA Inspection 853005 — Sure-Tech Diagnostic Associates, Inc
The FDA completed an inspection of Sure-Tech Diagnostic Associates, Inc on October 29, 2013 in Saint Louis, MO. 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
- October 29, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3668 | 21 CFR 820.20(c) | Management review dates |