FDA Inspection 1307166 — Perryman Company
The FDA completed an inspection of Perryman Company on March 10, 2026 in Houston, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 10, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Houston, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23230 | ISO 13485:2016 Clause 8.2.6 | Monitoring and measurement requirements of product characteristics are not met |
| 23254 | ISO 13485:2016 Clause 8.5.1 | Changes to maintain QMS and device not identified and implemented |