FDA Inspection 858168 — PerioSeal, Inc.
The FDA completed an inspection of PerioSeal, Inc. on December 11, 2013 in Little Rock, AR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 11, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Little Rock, AR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |