Synergy Health AST LLC, Lima, OH – FDA Inspections

Inspection records and compliance data for Synergy Health AST LLC in Lima, Ohio. 6 FDA inspections on record, 1 Form 483, last inspected April 30, 2018.

Company Profile

This profile covers Synergy Health AST LLC based in Lima, Ohio, United States.

FDA Inspection History

FDA inspections: 6
OAI: 0
VAI: 1
NAI: 5
Form 483s: 1
Warning letters: 0

First inspected January 5, 2011. Last inspected April 30, 2018.

Most cited issue areas

Lack of or inadequate procedures1 inspection
Nonconforming product, Lack of or inadequate procedures1 inspection
Process validation procedures1 inspection

FDA inspections (6)

Date	Result	FDA center(s)	Insp. #
April 30, 2018	NAI	Human Drugs · Drug Quality Assurance	1051030
August 2, 2017	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	1020211
June 10, 2015	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	930402
September 10, 2013	NAI	Medical Devices & Rad Health · Compliance: Devices	849490
January 23, 2013	NAI	Biologics, Human Drugs · Human Cellular, Tissue, and Gene Therapies	817800
January 5, 2011	VAI	Biologics, Medical Devices & Rad Health · Bioresearch Monitoring	704530

FDA documents

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

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