FDA Inspection 1325574 — Taylor Healthcare Products, Inc.
The FDA completed an inspection of Taylor Healthcare Products, Inc. on July 8, 2026 in Spring, TX. 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
- July 8, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Spring, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23024 | ISO 13485:2016 Clause 4.1.5 | Inadequate monitoring and control over outsourced processes |
| 23033 | ISO 13485:2016 Clause 4.2.1 | QMS documentation does not include required documents |
| 23215 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures lack required elements |