FDA Inspection
Fertility Technology Resources, Inc.Fertility Technology Resources, Inc. – FDA Inspection, Aug 10, 2017
Record Details
This FDA Inspection record concerns Fertility Technology Resources, Inc., with an inspection on August 10, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 37d091bd-321b-40aa-a88a-b345524f2c0d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1021059
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.50(a)(1)Documented evaluation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fertility Technology Resources, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 16, 2008 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Fertility Technology Resources, Inc.
- FDA Inspection 805304 - 2012-09-04
- FDA Inspection 546844 - 2008-10-16
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