FDA Inspection 1319292 — Hugh Steeper Ltd
The FDA completed an inspection of Hugh Steeper Ltd on May 28, 2026 in Hopkinton, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 28, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hopkinton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23162 | ISO 13485:2016 Clause 7.5.4 | Servicing procedures and reference materials and measurements not documented |
| 23266 | 21 CFR 820.35(b) | Records of servicing activities do not include required information |