FDA Inspection 1054686 — Centre Light Solutions, LLC
The FDA completed an inspection of Centre Light Solutions, LLC on May 30, 2018 in Mishawaka, IN. 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
- May 30, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mishawaka, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |