Caplin Point Laboratories on Thursday said its injectable facility has received an establishment inspection report (EIR) from the US health regulator after completion of an inspection.
Caplin Steriles… has received the establishment inspection report (EIR) from the United States Food and Drug Administration (USFDA) for the recently concluded inspection in June 2019, Caplin Point Laboratories said in a regulatory filing.
“We”re glad to receive the EIR within a short period of completing the inspection. Our commitment to maintaining the highest quality standards remain strong. We”re also starting to see traction in terms of product approvals and commercial batches being rolled out of this facility,” Caplin Point Laboratories Chairman C C Paarthipan said.
USFDA releases a copy of the EIR to the establishment that was the subject of an FDA or FDA-contracted inspection when the agency determines the inspection to be closed. – Outlook