# FDA 483 - Frontida BioPharm Inc - December 07, 2023

Source: https://www.globalkeysolutions.net/records/483/frontida-biopharm-inc/c91263e1-f4e2-4769-aada-9f498f973d1f

> FDA 483 for Frontida BioPharm Inc on December 07, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Frontida BioPharm Inc
- Inspection Date: 2023-12-07
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Frontida BioPharm Inc. in Philadelphia, PA, revealed two significant observations. The firm failed to submit Field Alert Reports within the required timeframe for distributed drug products affected by out-of-specification raw material. Additionally, the inspection found deficiencies in the cleaning validation studies for manufacturing equipment, specifically regarding multi-batch campaigns.

## Related Officers

- [Consumer Safety Officer ](https://www.globalkeysolutions.net/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.globalkeysolutions.net/companies/frontida-biopharm-inc/dc8190f9-0e13-4160-a611-dcf664f43b09

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