# Noven Pharmaceuticals Inc – FDA 483, Aug 24, 2026

Source: https://www.keypedia.com/records/483/noven-pharmaceuticals-inc/39396e04-3150-4a1e-86ba-253fe80be8b2

> FDA 483 for Noven Pharmaceuticals Inc on August 24, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Noven Pharmaceuticals Inc
- Inspection Date: 2026-08-24
- Product Type: drugs
- Office Name: Florida District Office
- Summary: Noven Pharmaceuticals, Inc. in Miami, FL, received a Form 483 with four observations related to quality control and data integrity during an inspection. The firm failed to perform in-house identity testing for drug product components and lacked proper controls for electronic data backup and access. Additionally, issues included insufficient second-person verification for laboratory records and inadequate controls over alarm setpoint changes in a critical system.

## Related Documents

- [483 - 2021-11-17](https://www.keypedia.com/records/483/noven-pharmaceuticals-inc/63c53ab2-0176-45dd-8d71-b4eb5e7b47bd) — date: November 17, 2021

## Related Officers

- [Michael Z. Weigman](https://www.keypedia.com/people/michael-z-weigman/fcf79bb1-87cc-476c-a1af-758ef0126ee9)

Company: https://www.keypedia.com/companies/noven-pharmaceuticals-inc/78cbceb0-5494-46a4-be87-8acf4450fa52

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