# FDA 483 - Aveva Drug Delivery Systems, Inc. - July 11, 2025

Source: https://www.globalkeysolutions.net/records/483/aveva-drug-delivery-systems-inc/9b6ea443-cb79-4741-84a5-84377da1ca5f

> FDA 483 for Aveva Drug Delivery Systems, Inc. on July 11, 2025. 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: 2025-07-11
- Product Type: drugs
- Office Name: Florida District Office
- Summary: An FDA inspection of Aveva Drug Delivery Systems Inc. in Tamarac, FL, revealed significant deficiencies in its quality control unit and laboratory operations. The firm lacked adequate scientific justification for commercial manufacturing of sterile drug products, including issues with master batch records, aseptic process simulations, cleaning validation, and analytical method verification. Additionally, the inspection found inadequate microbiological procedures and a deficient supplier qualification program, indicating a serious lack of control over critical manufacturing and testing processes.

## Related Documents

- [483 - 2025-07-11](https://www.globalkeysolutions.net/records/483/aveva-drug-delivery-systems-inc/5924fe6a-f76e-476a-948d-7e515b1a1b28)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)
- [Dennis Cantellops Paite](https://www.globalkeysolutions.net/people/dennis-cantellops-paite/3336bbb8-8520-4a8a-9085-76e7a55ca773)

Company: https://www.globalkeysolutions.net/companies/aveva-drug-delivery-systems-inc/12bab618-d462-4a98-a31b-c838a58a5116

Office: https://www.globalkeysolutions.net/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9