Sciarra Laboratories, Inc., Hicksville, NY – FDA Inspections

Inspection records and compliance data for Sciarra Laboratories, Inc. in Hicksville, New York. 11 FDA inspections on record, 2 Form 483s, last inspected August 07, 2023.

Company Profile

This profile covers Sciarra Laboratories, Inc. based in Hicksville, New York, United States.

FDA Inspection History

FDA inspections: 11
OAI: 0
VAI: 1
NAI: 10
Form 483s: 2
Warning letters: 0

First inspected March 25, 2009. Last inspected August 7, 2023.

Most cited issue areas

Control procedures to monitor and validate performance1 inspection
Equipment control activity documentation1 inspection
Establishment of calibration procedures1 inspection

FDA inspections (11)

Date	Result	FDA center(s)	Insp. #
August 7, 2023	VAI	Human Drugs · Drug Quality Assurance	1211562
March 29, 2018	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	1046128
February 14, 2018	NAI	Human Drugs, Medical Devices & Rad Health · Compliance: Devices	1041616
May 5, 2015	NAI	Human Drugs, Medical Devices & Rad Health · Compliance: Devices	925624
February 7, 2014	NAI	Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance	867806
October 4, 2012	NAI	Human Drugs, Medical Devices & Rad Health · Compliance: Devices	802381
October 7, 2011	NAI	Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance	748718
June 3, 2011	NAI	Human Drugs, Medical Devices & Rad Health · Compliance: Devices	727918
October 13, 2010	NAI	Medical Devices & Rad Health · Compliance: Devices	685307
May 12, 2010	NAI	Human Drugs · Drug Quality Assurance	664806
March 25, 2009	NAI	Human Drugs · Drug Quality Assurance	572309