# FDA 483 - MacroGenics, Inc - August 28, 2023

Source: https://www.keypedia.com/records/483/macrogenics-inc/fedf0c06-1015-481d-bcdc-fbb47b180ba9

> FDA 483 for MacroGenics, Inc on August 28, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MacroGenics, Inc
- Inspection Date: 2023-08-28
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: Macrogenics, Inc., a drug substance manufacturer in Rockville, MD, was cited with three observations during an FDA inspection. The observations highlight deficiencies in the firm's stability program, quality control unit procedures for HEPA filter certifications, and the thoroughness of investigations into unexplained discrepancies, including late stability testing and cleanroom air changes. These issues indicate a systemic failure to follow established procedures and adequately investigate deviations.

## Related Documents

- [483 - 2021-04-06](https://www.keypedia.com/records/483/macrogenics-inc/4868dff3-cad8-44fd-9bea-4a30e61b2c72)

## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.keypedia.com/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)

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

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64