FDA Inspection 1120204 — S&S X-Ray Products, Inc.
The FDA completed an inspection of S&S X-Ray Products, Inc. on Mar 9, 2020 in Houston, TX. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 9, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |