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US FDA Warning Letter Hits Strides On Data Integrity

Was blue binder of batch records in scrap yard a sign of deeper problems?

 
• By Bowman Cox

Even after the US FDA warns Strides on uncontrolled records destruction and poor OOS investigations at its Puducherry plant, firm remains confident in its US market growth projections.

Vintage inscription made by old typewriter, warning
us fda focused on data integrity in strides warning letter

A blue binder containing batch records for US-bound drug products was among the unreviewed documents, some dated as recently as a week before the facility inspection, that a US Food and Drug Administration investigator discovered in a 55-gallon drum in a Puducherry, India, drug manufacturing plant’s scrap yard.

The investigator saw other good manufacturing practice records during a 28 January to 5 February 2019 inspection of the Strides Pharma Inc

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