FDA Inspection 832516 — IsoAid, L.L.C.
The FDA completed an inspection of IsoAid, L.L.C. on May 10, 2013 in Port Richey, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 10, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Port Richey, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3115 | 21 CFR 820.70(h) | Use and removal, Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |