The receipt indicates the successful closure of the inspection and the queries raised during the audit
Unichem Laboratories has received an establishment inspection report (EIR) from the US health regulator for its formulation manufacturing facility in Ghaziabad.
“The company’s formulations manufacturing facility at Ghaziabad has received an establishment inspection report (EIR) from the US FDA. This receipt indicates the successful closure of the inspection and the queries raised during the audit (Form 483),” Unichem Laboratories said in a BSE filing.
It further said: “The inspection has now been closed by the US FDA. The inspection was carried out between February 24, 2017 and March 3, 2017.”
The US FDA 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.
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