# FDA 483 - Antares Pharma, Inc - May 13, 2022

Source: https://www.globalkeysolutions.net/records/483/antares-pharma-inc/f3dcf351-89d2-4712-9538-d19181b9c85e

> FDA 483 for Antares Pharma, Inc on May 13, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Antares Pharma, Inc
- Inspection Date: 2022-05-13
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Antares Pharma, Inc. in Minnetonka, MN, a human drug and medical device manufacturer, identified one observation. The firm was cited for not adequately establishing procedures for design changes, specifically regarding functional testing for subassembly release without proper validation or objective evidence.

## Related Documents

- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/antares-pharma-inc/09a825bf-bd7a-44e9-9075-89ce465a50b4)
- [483 - 2018-12-04](https://www.globalkeysolutions.net/records/483/antares-pharma-inc/c43ea21c-3bfc-4ce8-9472-5dba268734d4)
- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/antares-pharma-inc/4f29c602-74d8-4602-87c3-3527ed06d716)

## Related Officers

- [Brian D. Nicholson](https://www.globalkeysolutions.net/people/brian-d-nicholson/83ea13dd-6753-468a-a0ca-19e3ef4158dd)

Company: https://www.globalkeysolutions.net/companies/antares-pharma-inc/27f8256c-c1d6-4d41-b448-7fcac44937dc

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d