FDA Inspection 1304602 — Therapak Corporation
The FDA completed an inspection of Therapak Corporation on February 12, 2026 in Claremont, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 12, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Claremont, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23212 | ISO 13485:2016 Clause 8.2.1 | Feedback process procedures not documented |
| 23252 | ISO 13485:2016 Clause 8.4 | Analysis of data not used as input for QMS improvement where necessary |