FDA Inspection 1031823 — Chemence Medical Products Inc.
The FDA completed an inspection of Chemence Medical Products Inc. on Nov 21, 2017 in Alpharetta, GA. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 21, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Alpharetta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3841 | 21 CFR 820.90(b)(2) | Product rework adverse effects {see also 820.184} |