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# FDA Issues 3-item Form 483 After Strides India Inspection
- URL: https://www.fdaweb.com/fda-issues-3-item-form-483-after-strides-india-inspection/
- Published: 2017-06-05T12:00:00.000Z
- Updated: 2026-09-14T22:27:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138855

A just-concluded inspection of Strides Shasum Ltd. in Bangalore, India has resulted in a three-item [Form-483](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM561854.pdf?ref=fdaweb.com) citing GMP deficiencies concerning finished pharmaceuticals. For example, the agency said the firm conducted manufacturing investigations but did not arrive at a root cause to take corrective actions. Additionally, FDA found inadequate the firm’s scientific rationale to support its product sampling plan. And there were no written procedures for production and process controls, according to the 483.