Marina Medical Instruments Inc., Davie, FL – FDA Inspections

Inspection records and compliance data for Marina Medical Instruments Inc. in Davie, Florida. 8 FDA inspections on record (2 OAI), 1 Form 483, last inspected April 03, 2017.

Company Profile

This profile covers Marina Medical Instruments Inc. based in Davie, Florida, United States.

FDA Inspection History

FDA inspections: 8
OAI: 2
VAI: 4
NAI: 2
Form 483s: 1
Warning letters: 0

First inspected December 5, 2008. Last inspected April 3, 2017.

Most cited issue areas

Lack of or inadequate complaint procedures3 inspections
Lack of or inadequate procedures3 inspections
Lack of Written MDR Procedures3 inspections

FDA inspections (8)

Date	Result	FDA center(s)	Insp. #
April 3, 2017	VAI	Medical Devices & Rad Health · Compliance: Devices	1008782
January 9, 2014	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	862780
January 9, 2014	VAI	Medical Devices & Rad Health · Compliance: Devices	862654
January 9, 2014	VAI	Medical Devices & Rad Health · Compliance: Devices	862402
May 2, 2012	VAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	788539
May 2, 2012	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	788537
September 1, 2011	OAI	Medical Devices & Rad Health · Compliance: Devices	742816
December 5, 2008	OAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	550114

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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