FDA Inspection 1159288 — S. Jackson, Incorporated
The FDA completed an inspection of S. Jackson, Incorporated on Dec 10, 2021 in Alexandria, VA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Dec 10, 2021
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Alexandria, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |