FDA Inspection 879687 — Quest International, Inc.
The FDA completed an inspection of Quest International, Inc. on May 22, 2014 in Doral, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- May 22, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Doral, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3837 | 21 CFR 820.25(b) | Training records |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |