# FDA 483 - Noven Pharmaceuticals Inc - November 17, 2021

Source: https://www.keypedia.com/records/483/noven-pharmaceuticals-inc/63c53ab2-0176-45dd-8d71-b4eb5e7b47bd

> FDA 483 for Noven Pharmaceuticals Inc on November 17, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Noven Pharmaceuticals Inc
- Inspection Date: 2021-11-17
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Noven Pharmaceuticals Inc., a transdermal drug manufacturer in Miami, FL, was cited for four observations during an FDA inspection. The observations highlight significant issues with environmental controls, sanitation procedures, the thoroughness of investigations into discrepancies, and the review of batch records and equipment calibration. These findings indicate a need for improved quality system oversight and adherence to GMPs.

## Related Officers

- [Pharmaceutical Investigator](https://www.keypedia.com/people/kayla-v-sprague/154cb543-111b-4ad1-b45b-43900df71b90)
- [Jennifer Lalama](https://www.keypedia.com/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)
- [Lillian M Colon-McKnight](https://www.keypedia.com/people/lillian-m-colon-mcknight/ce6346b7-a006-4f84-afba-9fdda488042d)

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

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