STATLAB MEDICAL PRODUCTS, Mckinney, TX – FDA Inspections

Inspection records and compliance data for STATLAB MEDICAL PRODUCTS in Mckinney, Texas. 3 FDA inspections on record, last inspected April 20, 2016.

Company Profile

This profile covers STATLAB MEDICAL PRODUCTS based in Mckinney, Texas, United States.

FDA Inspection History

FDA inspections: 3
OAI: 0
VAI: 2
NAI: 1
Form 483s: 0
Warning letters: 0

First inspected April 22, 2011. Last inspected April 20, 2016.

Most cited issue areas

Absence of Written Procedures1 inspection
Cleaning/maintenance records not kept1 inspection
Containers & Closures Clean, Sterilized, Pyrogen-free1 inspection

FDA inspections (3)

Date	Result	FDA center(s)	Insp. #
April 20, 2016	VAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	970060
October 4, 2011	NAI	Human Drugs · Drug Quality Assurance	749124
April 22, 2011	VAI	Human Drugs · Drug Quality Assurance	723965

FDA documents

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

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