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# 3 Observations in Strides Pharma Science Inspection
- URL: https://www.fdaweb.com/3-observations-in-strides-pharma-science-inspection/
- Published: 2018-09-20T12:00:00.000Z
- Updated: 2026-09-15T00:33:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142401

An FDA pre-approval product inspection at the Strides Pharma Sciences formulations facility in Bangalore, India, was completed 8/25, resulting in issuance of an FDA-483 with three observations. The company [says](http://www.stridesarco.com/pdf/pressrelease/2018/completion%5Fof%5Fusfda%5Finspection%5Fat%5Fbangalore%5Ffacility%5F20180918.pdf?ref=fdaweb.com) it believes the agency’s observations are not material in nature and says it has already responded to FDA. Following completion of the inspection, it says, Strides received a product approval for potassium chloride extended release tablets from this facility.