FDA Inspection
The Keeper/ Moon Cup Inc.The Keeper/ Moon Cup Inc. – FDA Inspection, Aug 10, 2015
Record Details
This FDA Inspection record concerns The Keeper/ Moon Cup Inc., with an inspection on August 10, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- The Keeper/ Moon Cup Inc.
- Inspection Date
- August 10, 2015
- Product Type
- Devices
View Company Profile
ID · 8e2345d0-44d1-48e9-b7b2-24d53cc37d42
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 938456
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of The Keeper/ Moon Cup Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 31, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for The Keeper/ Moon Cup Inc.
- FDA Inspection 717179 - 2011-03-31
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