# FDA 483 - Spark Therapeutics, Inc. - August 25, 2017

Source: https://www.globalkeysolutions.net/records/483/spark-therapeutics-inc/2e64b039-fc19-4296-a3fc-b464ff3748c1

> FDA 483 for Spark Therapeutics, Inc. on August 25, 2017. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spark Therapeutics, Inc.
- Inspection Date: 2017-08-25
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Spark Therapeutics, Inc., a biologics drug substance manufacturer in Philadelphia, PA, was cited for significant quality system deficiencies. Observations included the untimely closure and review of deviations and investigations, a failure to consistently establish corrective actions for recurring human errors, and inadequacies in their CGMP training program, including a lack of periodic review of training records.

## Related Documents

- [483 - 2022-03-04](https://www.globalkeysolutions.net/records/483/spark-therapeutics-inc/8dd2825e-0b1c-4ca2-b73c-ea234760ec56)

## Related Officers

- [Lilia Bi, PhD](https://www.globalkeysolutions.net/people/lilia-bi-phd/7607e3c9-1322-4ec5-892b-6a35e28eecff)
- [Zeneida Torrapravata, PhD](https://www.globalkeysolutions.net/people/zeneida-torrapravata-phd/db18f9c0-bebd-4228-ad66-5cdf5de2d586)
- [Rubia BALUJA, PhD](https://www.globalkeysolutions.net/people/rubia-baluja-phd/e86ff732-e8d2-45a4-be8c-706b600bc227)

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd