FDA Inspection 1045736 — Rms Surgical, Inc.
The FDA completed an inspection of Rms Surgical, Inc. on Mar 23, 2018 in Memphis, TN. 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 23, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Memphis, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3149 | 21 CFR 820.180 | Availability |
| 3159 | 21 CFR 820.184 | DHR content |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |