FDA Inspection 1046981 — Conseal International, Inc.
The FDA completed an inspection of Conseal International, Inc. on Apr 5, 2018 in Fort Myers, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 5, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fort Myers, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1770 | 21 CFR 211.137(d) | Expiration date location on labeling |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |