FDA Inspection 1340262 — Surgical Instrument Manufacturers, LLC
The FDA completed an inspection of Surgical Instrument Manufacturers, LLC on Oct 8, 2026 in Fenton, MO. 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
- Oct 8, 2026
- Fiscal Year
- 2027
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fenton, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23080 | ISO 13485:2016 Clause 6.4.1 | Work environment requirements and procedures not documented |
| 23167 | ISO 13485:2016 Clause 7.5.6 | Process for production and service provision not validated |