# FDA 483 - MacroGenics, Inc - April 06, 2021

Source: https://www.globalkeysolutions.net/records/483/macrogenics-inc/4868dff3-cad8-44fd-9bea-4a30e61b2c72

> FDA 483 for MacroGenics, Inc on April 06, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MacroGenics, Inc
- Inspection Date: 2021-04-06
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: MacroGenics, Inc. in Rockville, MD, a drug substance manufacturer, was cited for multiple significant deficiencies during an FDA inspection. Observations included inadequate procedures for preventing microbiological contamination, insufficient controls for electronic data systems, and failures in cleaning validation, environmental control, and utility qualification. These issues indicate a lack of robust quality systems impacting product quality and data integrity.

## Related Documents

- [483 - 2023-08-28](https://www.globalkeysolutions.net/records/483/macrogenics-inc/fedf0c06-1015-481d-bcdc-fbb47b180ba9)

## Related Officers

- [Jeanne Fringer, Ph.D., Chemist](https://www.globalkeysolutions.net/people/jeanne-fringer-phd-chemist/c38f5762-9feb-4838-8624-6f213e06adbf)
- [Zhong Li, Ph.D.](https://www.globalkeysolutions.net/people/zhong-li-phd/cf5baf58-da51-4387-922f-a5d281c07632)
- [Li Lu, Ph.D.](https://www.globalkeysolutions.net/people/li-lu-phd/de25c2c8-b669-4561-a5b2-bc549e5cb084)

Company: https://www.globalkeysolutions.net/companies/macrogenics-inc/aaffc8e7-a7dc-4595-a5fb-2e95ee9315d1

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