# FDA 483 - Stille AB - September 28, 2023

Source: https://www.keypedia.com/records/483/stille-ab/5d96ad4a-115c-4f3e-82fc-878f55a02d5f

> FDA 483 for Stille AB on September 28, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stille AB
- Inspection Date: 2023-09-28
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Stille AB, a medical device manufacturer in Torshalla, Sweden, identified two significant observations. The firm's procedures for handling and investigating complaints were found to be inadequate, with several complaint investigations lacking proper documentation. Additionally, procedures for the acceptance of incoming critical components were not adequately established, as packing slips failed to document acceptance activity results.

## Related Documents

- [483 - 2023-09-28](https://www.keypedia.com/records/483/stille-ab/b573dec1-873e-4780-88f7-3f7f22ffa64d)

## Related Officers

- [Kenya Destin](https://www.keypedia.com/people/kenya-destin/1a367d64-8171-4dfd-bb1f-78d8b96a99f5)

Company: https://www.keypedia.com/companies/stille-ab/2f16f0d5-ab12-444a-a3aa-8ca22de10c71

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4