FDA Inspection 952765 — IsoAid, L.L.C.
The FDA completed an inspection of IsoAid, L.L.C. on December 22, 2015 in Port Richey, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- December 22, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Port Richey, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14715 | 21 CFR 820.30(d) | Design output - Lack of or inadequate procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |