Strides Pharma Science Limited has just been issued with an FDA Warning Letter (published 1 July 2019) following inspection of its Puducherry facility in India at the beginning of 2019. The first cited violation referred to uncontrolled shedding of cGMP records.
This isn’t the first Warning Letter in Strides’ history. Back in 2013, when Strides owned Agila Specialities, its plant in Bangalore received a Warning for lack of procedure to prevent microbiological contamination.
If you would like to find out more about Strides, Shasun and Agila Specialties’ regulatory violations (which includes FDA Enforcement Reports, FDA Drug Shortages, OAI Inspection Results and EDQM Certificate Withdrawal) then click on ‘Buy Now’ or sign up for a free trial on Regulatory Incident Monitor (where you can build your own reports about the companies that interest you the most).
Published: July 30 2019
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