FDA Inspection 1308246 — The Side Lyer Company LLC
The FDA completed an inspection of The Side Lyer Company LLC on March 12, 2026 in Orlando, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 12, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: 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 |