Ipca Labs gets warning letter from USFDA for 3 plants
New Delhi: Drug firm Ipca Laboratories has received warning letter from the US health regulator for three facilities on which the regulator had earlier imposed a import ban for not adhering to the good manufacturing norms.
"We wish to inform you that United States Food and Drug Administration (USFDA) has now issued a warning letter to these manufacturing units," Ipca Laboratories said in a BSE filing.
The company is fully committed in resolving the issue at the earliest, it added.
The company, however, did not provide the details of the warning letter.
Earlier in regulatory filings to the bourses, Ipca had said that USFDA after inspections at its manufacturing units situated at Ratlam, SEZ Indore and Piparia had issued Form 483 observations "which subsequently resulted in issuance of import alert on these manufacturing units."
The company has already voluntarily suspended shipments of its APls and formulations for the US market and since July 2014 has not shipped any APls or formulations to the US market except the products which are exempted from import alert, it added.
"The company has responded to USFDA inspection observations with its remediation measures and has been since working also with external consultants to ensure that its remedial activities are undertaken in a proper and timely manner," Ipca Laboratories said.
"We wish to inform you that United States Food and Drug Administration (USFDA) has now issued a warning letter to these manufacturing units," Ipca Laboratories said in a BSE filing.
The company is fully committed in resolving the issue at the earliest, it added.
The company, however, did not provide the details of the warning letter.
Earlier in regulatory filings to the bourses, Ipca had said that USFDA after inspections at its manufacturing units situated at Ratlam, SEZ Indore and Piparia had issued Form 483 observations "which subsequently resulted in issuance of import alert on these manufacturing units."
The company has already voluntarily suspended shipments of its APls and formulations for the US market and since July 2014 has not shipped any APls or formulations to the US market except the products which are exempted from import alert, it added.
"The company has responded to USFDA inspection observations with its remediation measures and has been since working also with external consultants to ensure that its remedial activities are undertaken in a proper and timely manner," Ipca Laboratories said.
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