FDA Inspection 1013014 — Integrity Systems LLC
The FDA completed an inspection of Integrity Systems LLC on June 6, 2017 in Olive Branch, MS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 6, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Olive Branch, MS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3159 | 21 CFR 820.184 | DHR content |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |