FDA Inspection 723955 — Hardy Diagnostics
The FDA completed an inspection of Hardy Diagnostics on April 15, 2011 in Santa Maria, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 15, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Santa Maria, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3111 | 21 CFR 820.70(f) | Buildings |
| 3139 | 21 CFR 820.140 | Lack of or inadequate procedures for handling |
| 3175 | 21 CFR 820.186 | QSR |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |