1. USFDA issues 6 observations post Indoco’s Goa plant inspection

USFDA issues 6 observations post Indoco’s Goa plant inspection

Drug firm Indoco Remedies today said the US health regulator has inspected its Goa plant and has issued six observations on account of violation of good manufacturing norms.

By: | New Delhi | Published: September 7, 2016 4:43 PM

Drug firm Indoco Remedies today said the US health regulator has inspected its Goa plant and has issued six observations on account of violation of good manufacturing norms.

“The United States Food and Drug Administration (USFDA) inspected the company’s Goa Plant II from August 31, 2016 to September 4, 2016,” Indoco Remedies said in a BSE filing.

The injectable abbreviated new drug application (ANDA) filings triggered this inspection, it added.

“At the end of the inspection, six 483s (forms) were issued. All the observations(483s) are correctable and the company expects to complete the corrective and preventive actions within a period of 30 days,” Indoco Remedies said.

None of the 483s are related to data integrity issue, it added.

As per the FDA, “an FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts.”

Shares of Indoco Remedies closed 2.72 per cent higher at Rs 330.05 per scrip on BSE today.

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