# FDA 483 - Ion Labs Inc. - April 28, 2023

Source: https://www.globalkeysolutions.net/records/483/ion-labs-inc/6584eb04-ab38-4610-a647-91f4a1a5efa3

> FDA 483 for Ion Labs Inc. on April 28, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ion Labs Inc.
- Inspection Date: 2023-04-28
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Ion Labs Inc., a drug manufacturer and repacker in Largo, FL, received a Form 483 with four observations during an FDA inspection. The firm was cited for deficiencies including a lack of equipment qualification and validation for a blister pack machine, inadequate quality control unit oversight of electronic records and data integrity, and insufficient laboratory controls. Additionally, the inspection revealed failures in conducting complete investigations into unexplained production discrepancies.

## Related Documents

- [483 - 2011-06-03](https://www.globalkeysolutions.net/records/483/ion-labs-inc/df7cd3b8-58fb-4dcf-acf0-db9b221c5f63)
- [483 - 2012-08-02](https://www.globalkeysolutions.net/records/483/ion-labs-inc/a691a974-e1a3-4986-a3ae-b44932ccd3ca)
- [483 - 2013-05-07](https://www.globalkeysolutions.net/records/483/ion-labs-inc/ef75e67e-0e16-4276-98d9-e0f6dce6d57c)
- [483 - 2016-05-12](https://www.globalkeysolutions.net/records/483/ion-labs-inc/6122ec3d-9a7b-4cd9-9f0b-4a940aa7f965)
- [483 - 2022-12-06](https://www.globalkeysolutions.net/records/483/ion-labs-inc/c92d11ca-82db-4654-8c33-7eec08d04931)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)
- [Investigator ](https://www.globalkeysolutions.net/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)

Company: https://www.globalkeysolutions.net/companies/ion-labs-inc/2b89e113-4ab2-48d1-a46e-039fd92262df

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6