US FDA completes inspection of Strides Shasun's Bangalore facility

Stride Shasun Ltd yesterday announced successful completion of US FDA inspection at its flagship oral dosage facility in Bangalore with 'zero 483s'. A Form 483 is issued by US FDA for violations of current good manufacturing practices which if unaddressed can lead to a warning letter or import alert by the regulator.

The audit was carried out related to a product filed from the new semi solids block from where the company has made a series of filings.

With the recently closed establishment inspection report (EIR) announced on June 7, 2016, the entire facility is now US FDA compliant.

The oral dosage facility in Bangalore manufactures oral dosage forms including tablets, capsules (both hard gelatine and soft gelatine), ointments and liquids. The manufacturing plant supports important current and future submissions for the US market.