FDA Inspection 1021059 — Fertility Technology Resources, Inc.
The FDA completed an inspection of Fertility Technology Resources, Inc. on August 10, 2017 in Murphy, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 10, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Murphy, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14711 | 21 CFR 820.160(a) | Lack of or inadequate procedures for distribution |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |