FDA Inspection
MRP, LLC dba AquabilitiMRP, LLC dba Aquabiliti – FDA Inspection, Oct 24, 2008
Record Details
This FDA Inspection record concerns MRP, LLC dba Aquabiliti, with an inspection on October 24, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MRP, LLC dba Aquabiliti
- Inspection Date
- October 24, 2008
- Product Type
- Devices
View Company Profile
ID · 7818f292-3849-4daf-82a6-dec3e322668b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 545087
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(b)(1)Responsibility, authority and independence
- 21 CFR 820.25(b)Training records
- 21 CFR 820.20Management responsibility
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.20(a)Quality policy and objectives
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Other FDA inspections of MRP, LLC dba Aquabiliti
8| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 27, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 28, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 23, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 7, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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