FDA Inspection 1163354 — Blue Chip Medical Products, Inc.
The FDA completed an inspection of Blue Chip Medical Products, Inc. on February 18, 2022 in Suffern, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 18, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Suffern, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |