# FDA 483 - Strides Pharma, Inc. - June 05, 2019

Source: https://www.keypedia.com/records/483/strides-pharma-inc/d21b9f23-7574-41a0-b2f4-3e07d4c01d00

> FDA 483 for Strides Pharma, Inc. on June 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Strides Pharma, Inc.
- Inspection Date: 2019-06-05
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Par Pharmaceutical, Inc. in Chestnut Ridge, NY, received a Form 483 citing significant deficiencies in their manufacturing processes and laboratory controls. The inspection revealed inadequate written procedures for equipment cleaning validation and maintenance, including a flawed matrix approach and lack of defined cleaning times. Additionally, laboratory controls were found to be deficient, with analytical methods for drug product purity failing to quantify known impurities.

## Related Documents

- [483 - 2015-06-04](https://www.keypedia.com/records/483/strides-pharma-inc/63032206-1b32-4f0d-93f9-e9d10e0b9e76)
- [483 - 2022-02-20](https://www.keypedia.com/records/483/strides-pharma-inc/46f0493f-7964-4155-8ae7-ae66f6fbb60f)
- [483 - 2025-12-23](https://www.keypedia.com/records/483/strides-pharma-inc/f3689b12-9453-4bd3-a59a-6a5021105b07)

## Related Officers

- [Consumer Safety Officer Drug Specialist](https://www.keypedia.com/people/sony-mathews/4d42379f-1245-494c-8c19-6cefa4e560a5)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961