Dr Reddy’s Visakhapatnam unit not cleared by USFDA even after EIR
Mumbai: Dr Reddy’s Laboratories Ltd said on Tuesday that the US Food and Drug Administration (FDA) has issued a procedural Establishment Inspection Report (EIR) to its cancer drugs facility at Duvvada in Visakhapatnam following the plant audit in March this year but the inspection has not been closed and warning letter on the unit stays.
An EIR is issued by the USFDA on successful completion of a site inspection. It usually indicates closure of the inspection but in case of Dr Reddy’s the EIR is merely issued for the sake of transparency from the US regulator.
“In the cover letter to the EIR, FDA has explained that the inspection has not closed and the site’s status remains unchanged, but the FDA has released the EIR in order to be transparent about its regulatory process,” Dr Reddy’s said in a stock exchange filing.
Shares of Dr Reddy’s jumped 9% on news of the receipt of EIR but shed some gains later as the plant’s status remains unchanged. At 1pm, the stock was up 4.5% at Rs2,379.60 on the BSE, while benchmark Sensex index was up 0.5% at 33,530.07 points.
The company plans to invite the USFDA for a re-inspection of the Duvvada unit in 2018, it said in the filing.
While the warning letter status of the Duvvada plant remains unchanged, this EIR has eased concerns over regulatory issues escalating to an import alert, a Mumbai-based analyst, who did not wish to be named, said. If a firm fails to resolve issues highlighted in a warning letter for a plant, the USFDA can impose an import ban on products made at that facility.
A consultant said that USFDA usually issues an EIR within six months of inspection of a site and it is a full-blown detailed report of the findings of the audit. With Dr Reddy’s it seems that the remediation work is still ongoing and though as part of the process the USFDA has issued an EIR, the plant is yet not cleared.
Post the March audit of the facility, the US drug regulator had issued a Form 483 with 13 observations relating to deviations from current good manufacturing practices (cGMP).
The FDA issues a Form 483 if its investigators spot any conditions that in their judgment may constitute violations of the US Food Drug and Cosmetic (FD&C) Act and related laws.
The Duvvada unit is one of the three plants that had received a warning letter from the USFDA for breach of norms in November 2015. Two active pharmaceutical ingredients (API) facilities at Miryalaguda and Srikakulam had also received warning letters.
The USFDA cleared the company’s Miryalaguda plant in June this year, while its Srikakulam unit stays under the warning letter.
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