FDA Inspection 1308266 — Reprolife America, LLC
The FDA completed an inspection of Reprolife America, LLC on March 20, 2026 in Kingwood, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 20, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kingwood, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23016 | ISO 13485:2016 Clause 4.1.1 | QMS not documented and maintained adequately |
| 23036 | ISO 13485:2016 Clause 4.2.3 | Medical device file not established and maintained |
| 23080 | ISO 13485:2016 Clause 6.4.1 | Work environment requirements and procedures not documented |
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23131 | ISO 13485:2016 Clause 7.3.9 | Significance of design and development changes not determined |
| 23137 | ISO 13485:2016 Clause 7.3.10 | Design and development file does not include or reference required records |
| 23167 | ISO 13485:2016 Clause 7.5.6 | Process for production and service provision not validated |
| 23184 | ISO 13485:2016 Clause 7.5.9.1 | Procedures for traceability were not documented |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |