Drug firm Indoco Remedies Wednesday said the US health regulator has issued four observations after inspection of its manufacturing facility in Goa.
"The US Food and Drug Administration (USFDA) conducted audit at Indoco's sterile manufacturing facility in Verna, Goa (Plant II) from May 27 to June 4, 2019, issuing 4 observations (483s)," the company said in a filing to BSE.
These observations are procedural in nature, not pertaining to data integrity, it added.
The company did not disclose the details of the observations made by the regulator but said it will submit its response shortly.
"The recent USFDA inspection was a scheduled Prior Approval Inspection for injectable products, filed from this facility. We are hopeful for an early and successful closure of this audit, which will expedite approvals of the pending abbreviated new drug applications (ANDAs)," MD Aditi Kare Panandikar said.
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