Successful USFDA Clinical Inspection – Lambda Canada Facility
It is with great pride we inform the successful closure of the USFDA inspection conducted last week between 15th May 2017 to 18th May 2017 at our Toronto facilities (Lambda Canada).
Inspection was conducted as a part of routine Bioequivalent Clinical Bioresearch Monitoring (BIMO) inspection program of USFDA wherein the clinical phases of multiple selected studies were reviewed by the Agency. There were no inspectional observations and no FDA 483s’ were issued for the ANDA submission studies inspected.
With this accomplishment, we pride ourselves in having successfully concluded all USFDA inspections carried out over the past many years in all our global locations Ahmedabad and Mumbai, India and Toronto, Canada wherein multiple studies ranging from routine BE, Phase-1 and Patient based clinical studies have been randomly inspected. We have no outstanding clarifaxes and all the previous EIR’s have been received from the Agency.
We believe these accomplishments are testimony of our overall commitment to Quality and International Regulatory Compliance in the Clinical domain and thank you once again for your continued support and patronage of Lambda Therapeutic Research for your ANDA submissions.