FDA Inspection 1008504 — Peter Schiff Enterprises
The FDA completed an inspection of Peter Schiff Enterprises on April 13, 2017 in Cookeville, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 13, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Cookeville, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |