FDA Inspection
Sepal Reproductive Devices, Inc.Sepal Reproductive Devices, Inc. – FDA Inspection, May 26, 2010
Record Details
This FDA Inspection record concerns Sepal Reproductive Devices, Inc., with an inspection on May 26, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 26, 2010
- Product Type
- Devices
View Company Profile
ID · 27157e76-7bec-454d-9ef7-8bd99303ccb7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 665628
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sepal Reproductive Devices, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 26, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sepal Reproductive Devices, Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.