# FDA 483 - Strides Pharma, Inc. - December 23, 2025

Source: https://www.keypedia.com/records/483/strides-pharma-inc/f3689b12-9453-4bd3-a59a-6a5021105b07

> FDA 483 for Strides Pharma, Inc. on December 23, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Strides Pharma, Inc.
- Inspection Date: 2025-12-23
- Product Type: drugs
- Office Name: New York District Office
- Summary: Strides Pharma, Inc. in Chestnut Ridge, NY, was inspected and received a Form 483 with four observations primarily concerning quality control and manufacturing practices. The inspection revealed deficiencies in equipment cleaning validation, microbial method suitability studies, microbiology testing procedures, and equipment calibration documentation. These issues indicate potential risks to drug product quality, identity, strength, and purity.

## Related Documents

- [483 - 2015-06-04](https://www.keypedia.com/records/483/strides-pharma-inc/63032206-1b32-4f0d-93f9-e9d10e0b9e76)
- [483 - 2019-06-05](https://www.keypedia.com/records/483/strides-pharma-inc/d21b9f23-7574-41a0-b2f4-3e07d4c01d00)
- [483 - 2022-02-20](https://www.keypedia.com/records/483/strides-pharma-inc/46f0493f-7964-4155-8ae7-ae66f6fbb60f)

## Related Officers

- [Josh Renzo N. Ramilo](https://www.keypedia.com/people/josh-renzo-n-ramilo/5b0850ba-e22a-42fc-9310-2beeb921f8f6)
- [investigator](https://www.keypedia.com/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

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

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d