FDA Inspection 1306818 — Seriously Clean, Ltd.
The FDA completed an inspection of Seriously Clean, Ltd. on March 11, 2026 in Nixa, MO. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 11, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Nixa, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 23145 | ISO 13485:2016 Clause 7.4.1 | Records of supplier (re)evaluation, selection, and monitoring not maintained |
| 23194 | ISO 13485:2016 Clause 7.6(a) | Measuring equipment not adequately calibrated or verified |