FDA Inspection 1320104 — THERAPAK LLC
The FDA completed an inspection of THERAPAK LLC on June 2, 2026 in Oakwood, GA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 2, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Oakwood, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23150 | ISO 13485:2016 Clause 7.4.3 | Purchased product verification activities not established or implemented |