US FDA alert for import of one of the skin care product to Strides Acrolab

Strides Acrolab is a Bangalore Based pharmaceutical company.US FDA has put alert on one of the skin care product of the company which according to the company has approval to supply only in Africa and not in US. US FDA have already released a 483 and a warning letter to the company in the past and this is the second time when US FDA has again raised an issue.

The product is being manufactured by Strides Italian subsidiary; Beltapharm which is supplying to an African customer from almost past 5 years and is not having any clue of how any of these products have been distributed in the US territory.

According to the company it has only one Abbreviated New Drug Application approval for its Imiquimod cream for the US market which has been launched recently and is freely available.