# FDA 483 - Strides Pharma, Inc. - February 20, 2022

Source: https://www.keypedia.com/records/483/strides-pharma-inc/46f0493f-7964-4155-8ae7-ae66f6fbb60f

> FDA 483 for Strides Pharma, Inc. on February 20, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Strides Pharma, Inc.
- Inspection Date: 2022-02-20
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Strides Pharma, Inc. in Chestnut Ridge, NY, a drug manufacturer, revealed significant deficiencies in both laboratory control mechanisms and packaging/labeling operations. The firm failed to properly document laboratory analyses, ensure QC review, and maintain appropriate sample storage. Additionally, inadequate cleaning procedures led to residual labeled materials on packaging lines after batch runs.

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## Related Officers

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Company: https://www.keypedia.com/companies/strides-pharma-inc/e9e4da51-c260-486c-8969-86d64b9b36af

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248