# FDA 483 - Abbott Medical - June 28, 2023

Source: https://www.globalkeysolutions.net/records/483/abbott-medical/cf3eb882-59fc-400e-81b3-890d9b23e187

> FDA 483 for Abbott Medical on June 28, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abbott Medical
- Inspection Date: 2023-06-28
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Abbott Medical in Sylmar, CA, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to report corrections and removals for implantable cardiac devices with Bluetooth communication issues that could lead to serious injury or death. Additionally, procedures for corrective and preventive actions and complaint handling were found to be inadequate, with numerous complaints misclassified and not properly evaluated for Medical Device Report (MDR) reportability.

## Related Documents

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- [483_RESPONSE - 2012-10-17](https://www.globalkeysolutions.net/records/483_response/abbott-medical/581f7586-f63a-4294-825a-35efa937ef9d)
- [WARNING_LETTER_RESPONSE - 2012-10-17](https://www.globalkeysolutions.net/records/warning_letter_response/abbott-medical/854517be-9bd0-4d90-a954-b5ddc35520d7)
- [483 - 2017-02-17](https://www.globalkeysolutions.net/records/483/abbott-medical/c5d1c4b8-f3d9-4f03-88e4-d6825bfb70bf)
- [483 - 2019-08-02](https://www.globalkeysolutions.net/records/483/abbott-medical/485be1aa-9f15-467f-9ad4-1739c25d4903)

## Related Officers

- [Kenya Destin](https://www.globalkeysolutions.net/people/kenya-destin/1a367d64-8171-4dfd-bb1f-78d8b96a99f5)
- [Investigator](https://www.globalkeysolutions.net/people/janet-pulver/d46b01cd-8c3d-4a54-bb91-843e0f94de89)

Company: https://www.globalkeysolutions.net/companies/abbott-medical/9609a880-3ad7-48ea-905b-9faaf9179e85

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6