FDA Inspection 1329598 — Freeland Systems, Llc
The FDA completed an inspection of Freeland Systems, Llc on Jul 17, 2026 in Carmel, IN. 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). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 17, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Carmel, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23036 | ISO 13485:2016 Clause 4.2.3 | Medical device file not established and maintained |
| 23044 | ISO 13485:2016 Clause 4.2.5 | Procedures for control of records not documented |
| 23060 | ISO 13485:2016 Clause 5.6.1 | Management review procedures not documented |
| 23130 | ISO 13485:2016 Clause 7.3.9 | Procedures to control design and development changes not documented |
| 23138 | ISO 13485:2016 Clause 7.4.1 | Procedures for purchasing process not documented |
| 23221 | ISO 13485:2016 Clause 8.2.4 | Internal audit procedures not documented |
| 23249 | ISO 13485:2016 Clause 8.4 | Procedures for analysis of data not documented |