# FDA 483 - Antares Pharma, Inc - December 04, 2018

Source: https://www.globalkeysolutions.net/records/483/antares-pharma-inc/c43ea21c-3bfc-4ce8-9472-5dba268734d4

> FDA 483 for Antares Pharma, Inc on December 04, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Antares Pharma, Inc
- Inspection Date: 2018-12-04
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Antares Pharma, Inc. in Minneapolis, MN, was inspected by the FDA from November 27 to December 4, 2018. The inspection revealed that corrective and preventive action activities were not adequately documented. Specifically, Supplier Corrective Action Requests (SCARs) lacked proper documentation of actions and verification of effectiveness.

## Related Documents

- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/antares-pharma-inc/09a825bf-bd7a-44e9-9075-89ce465a50b4)
- [483 - 2022-05-13](https://www.globalkeysolutions.net/records/483/antares-pharma-inc/f3dcf351-89d2-4712-9538-d19181b9c85e)
- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/antares-pharma-inc/4f29c602-74d8-4602-87c3-3527ed06d716)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/susan-m-matthias/cd23c465-4411-4988-8676-2089e265622a)

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