FDA Inspection 1328776 — Lynn Medical Instrument Co.
The FDA completed an inspection of Lynn Medical Instrument Co. on Jul 31, 2026 in Wixom, MI. 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). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 31, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Wixom, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23016 | ISO 13485:2016 Clause 4.1.1 | QMS not documented and maintained adequately |
| 23028 | ISO 13485:2016 Clause 4.1.6 | QMS software not validated prior to use or changes |
| 23088 | ISO 13485:2016 Clause 7.1 | Records of risk management activities in product realization not maintained |
| 23141 | ISO 13485:2016 Clause 7.4.1 | Supplier monitoring and re-evaluation not planned |
| 23150 | ISO 13485:2016 Clause 7.4.3 | Purchased product verification activities not established or implemented |
| 23219 | ISO 13485:2016 Clause 8.2.2 | Complaint handling records not maintained |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |
| 4208 | 21 CFR 806.20(a) | Records not kept |