# FDA 483 - AVEVA Drug Delivery Systems, Inc. - September 01, 2023

Source: https://www.keypedia.com/records/483/aveva-drug-delivery-systems-inc/c36cc387-5a3a-4e33-b4cb-bf8d9253d9b1

> FDA 483 for AVEVA Drug Delivery Systems, Inc. on September 01, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AVEVA Drug Delivery Systems, Inc.
- Inspection Date: 2023-09-01
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of AVEVA Drug Delivery Systems, Inc. in Miramar, FL, revealed two significant observations. The firm failed to limit access to label and labeling material storage areas to authorized personnel, with a broken gate observed for months. Additionally, washing and toilet facilities lacked readily available hot and cold water in multiple locations.

## Related Documents

- [483 - 2019-07-26](https://www.keypedia.com/records/483/aveva-drug-delivery-systems-inc/a5d313a9-e652-474f-b6cb-e57f2260ecea)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)

Company: https://www.keypedia.com/companies/aveva-drug-delivery-systems-inc/54790ed2-6912-4f90-8120-2e933adcfa47

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