FDA Inspection 889188 — Simply Clean Air & Water Inc.
The FDA completed an inspection of Simply Clean Air & Water Inc. on July 18, 2014 in Newington, CT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 18, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Newington, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3159 | 21 CFR 820.184 | DHR content |
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 3323 | 21 CFR 820.170(b) | Installer records |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |