# FDA 483 - AMO Uppsala AB - Unknown Date

Source: https://www.keypedia.com/records/483/amo-uppsala-ab/33015108-b034-44bf-a7b1-6e45024be89a

> FDA 483 for AMO Uppsala AB on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AMO Uppsala AB
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of AMO Uppsala AB in Uppsala, Sweden, a medical device manufacturer, identified significant issues in process validation and nonconformance management. The firm's validation protocols for device manufacturing were found to be inadequate, lacking comprehensive testing, proper documentation, and calibration procedures. Additionally, the inspection revealed deficiencies in documenting and evaluating nonconforming devices, including instances of devices being reprocessed without proper tracking and devices falling on the floor without being identified as nonconforming.

## Related Officers

- [Sean T. Creighton](https://www.keypedia.com/people/sean-t-creighton/80ffecab-0a2d-4727-a11f-407b697f4503)

Company: https://www.keypedia.com/companies/amo-uppsala-ab/9de01835-06d7-4b2d-8cf8-0a482613d2f7

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd