FDA Inspection
Merit Medical Systems, Inc.Merit Medical Systems, Inc. – FDA Inspection, Sep 27, 2016
Record Details
This FDA Inspection record concerns Merit Medical Systems, Inc., with an inspection on September 27, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Merit Medical Systems, Inc.
- Inspection Date
- September 27, 2016
- Product Type
- Devices
View Company Profile
ID · 9b560f91-e985-4b70-b387-7155c329db03
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 988792
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Merit Medical Systems, Inc.
12| Date | Classification | Office | Project area |
|---|---|---|---|
| September 9, 2024 | Not classified | Dallas District Office | |
| January 15, 2019 | Not classified | Dallas District Office | |
| October 25, 2018 | Not classified | Dallas District Office | |
| January 19, 2018 | Not classified | Dallas District Office | |
| June 23, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Merit Medical Systems, Inc.
- FDA Inspection 1250853 - 2024-09-09
- FDA Inspection 1097035 - 2019-01-15
- FDA Inspection 1109788 - 2018-10-25
- FDA Inspection 1087233 - 2018-01-19
- FDA Inspection 977545 - 2016-06-23
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