1308246
The Side Lyer Company LLC — FEI 3030492371
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 12, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 23021 | ISO 13485:2016 Clause 4.1.3 | QMS process records not established or maintained |
| 23043 | ISO 13485:2016 Clause 4.2.5 | Records of conformity and QMS operations not maintained |
| 23071 | ISO 13485:2016 Clause 6.2(a) | Necessary personnel competence not determined |
| 23088 | ISO 13485:2016 Clause 7.1 | Records of risk management activities in product realization not maintained |
| 23133 | ISO 13485:2016 Clause 7.3.9 | Requirements for design and development changes not met before implementation |
| 23138 | ISO 13485:2016 Clause 7.4.1 | Procedures for purchasing process not documented |