Facility

Compliance Statements

Ref: ITPL FEI#1000208853. FDA Registration# 2248015. DUNS # 808304844. Labeler Code#061230 GLP and CGMP Certificate

ITPL LABS is an independent FDA-registered laboratory that provides service to the Pharmaceuticals industries, Nutritions and food Industrials. ITPL LABS as an independent contract testing laboratory strives to fully comply with the appropriate regulatory requirement such as Current good Manufacturing Practices as codified in 21 CFR Part 210 & 211 and when requested Good Laboratory Practices as codified in 21 CFR Part 58 or 40 CFR Part 160 or 792.

This is to certify that ITPL LABS is in full compliance with the Federal, State, and Town regulatory requirements. ITPL LABS is currently in good standing with the FDA, for the last several years FDA compliance Inspections revealed no 483. The facility was last inspected in June 2013 with no deficiencies.

This is to further certify that ITPL LABS has not been debarred by the FDA nor is it currently involved in a debarment proceeding with the FDA. No person employed by ITPL LABS has currently or in the past five years been convicted of any crime described in Section 306 (a) or (b) of Generic Drug Enforcement Act of 1992 and ITPL LABS does not and will not knowingly use the services of any person debarred under section 360 (a) or (b) of the Generic Drug Enforcement Act of 1992.

You can look up for our facility on the website by the FEI number; (GDUFA) http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm

FY 2014: Self-Identified Generic Drug Facilities, Sites and Organizations List (XLS - 1.6MB)

Or you can look for our facility by Name at: http://www.accessdata.fda.gov/scripts/cder/drls/

Newsletter