FDA Inspection 1031705 — Genesis BPS, LLC.
The FDA completed an inspection of Genesis BPS, LLC. on Nov 20, 2017 in Mahwah, NJ. 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
- Nov 20, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mahwah, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |