# FDA 483 - Abbott Medical - November 23, 2022

Source: https://www.globalkeysolutions.net/records/483/abbott-medical/9c644cc5-0cd4-44e5-8895-fc1ba85dea7a

> FDA 483 for Abbott Medical on November 23, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abbott Medical
- Inspection Date: 2022-11-23
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of Abbott Medical in Arecibo, PR, revealed a significant deficiency in the documentation of corrective and preventive action (CAPA) activities. Specifically, a CAPA related to an adverse trend in pacemakers, which could lead to loss of pacing, lacked clear documentation for the rationale behind the scope of a field action. This resulted in an initial field action that did not include all potentially affected devices, necessitating a later expansion.

## Related Documents

- [483 - 2012-10-02](https://www.globalkeysolutions.net/records/483/abbott-medical/89799de5-1e73-4d64-81e5-272be8ec1ffa)
- [483_RESPONSE - 2012-10-02](https://www.globalkeysolutions.net/records/483_response/abbott-medical/9fdd5910-d156-48fc-8f57-d47c995ed5ed)

## Related Officers

- [Adaliz Santaliz-Cruz](https://www.globalkeysolutions.net/people/adaliz-santaliz-cruz/47bd4220-e6cc-4582-a4f5-bd4337f92622)

Company: https://www.globalkeysolutions.net/companies/abbott-medical/5402bde4-6e65-429a-b770-28a7f6e13f26

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6