# FDA 483 - Frontier Therapeutics inc. - January 08, 2020

Source: https://www.globalkeysolutions.net/records/483/frontier-therapeutics-inc/ea010f9d-0466-43ea-964b-924f7e169d14

> FDA 483 for Frontier Therapeutics inc. on January 08, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Frontier Therapeutics inc.
- Inspection Date: 2020-01-08
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Frontier Therapeutics Inc., a medical device initial importer in Buffalo, NY, identified one significant observation. The firm's procedures for corrective and preventive actions (CAPA) were found to be inadequately established. This indicates a deficiency in their quality system regarding problem investigation, corrective action implementation, and effectiveness verification.

## Related Officers

- [Matthew D. Schnittker](https://www.globalkeysolutions.net/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.globalkeysolutions.net/companies/frontier-therapeutics-inc/b5114b52-7b82-4340-97c4-8f9dfee98f31

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961