# FDA 483 - Spark Therapeutics, Inc. - March 04, 2022

Source: https://www.globalkeysolutions.net/records/483/spark-therapeutics-inc/8dd2825e-0b1c-4ca2-b73c-ea234760ec56

> FDA 483 for Spark Therapeutics, Inc. on March 04, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spark Therapeutics, Inc.
- Inspection Date: 2022-03-04
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Spark Therapeutics Inc. in Philadelphia, Pennsylvania, a drug substance manufacturer, received a Form 483 citing significant issues across its manufacturing and quality systems. Observations included repeated process deviations with insufficient stability data, inadequate Out of Specification investigations and change control for analytical methods, and a critical lack of quality oversight for contract manufacturers of its Luxturna product. These findings indicate deficiencies in process control, quality unit responsibilities, and vendor management.

## Related Documents

- [483 - 2017-08-25](https://www.globalkeysolutions.net/records/483/spark-therapeutics-inc/2e64b039-fc19-4296-a3fc-b464ff3748c1)

## Related Officers

- [Principal Consultant- CMC Biologics, Former FDA regulator with expertise in CMC and GMP for Biologics](https://www.globalkeysolutions.net/people/steven-e-bowen/0e32c7e6-285b-4cf1-90e1-8a7a12a38b0c)
- [Bradley C. Croft](https://www.globalkeysolutions.net/people/bradley-c-croft/db0bc088-df39-445c-a2e1-a5fc4334c206)
- [investigator](https://www.globalkeysolutions.net/people/jacqueline-m-diaz-albertini/9ff937fe-4e9b-445a-80fa-e26800d923b8)

Company: https://www.globalkeysolutions.net/companies/spark-therapeutics-inc/a5518493-a117-41d3-862d-96d5a5d3b6dd

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8