FDA Inspection 1271061 — Optim LLC
The FDA completed an inspection of Optim LLC on May 29, 2025 in Sturbridge, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 29, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Sturbridge, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3159 | 21 CFR 820.184 | DHR content |