FDA Inspection 801414 — Howard Instruments Inc
The FDA completed an inspection of Howard Instruments Inc on October 4, 2012 in Tuscaloosa, AL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 4, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tuscaloosa, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |