# FDA 483 - Mohnark Pharmaceuticals Inc - February 25, 2022

Source: https://www.keypedia.com/records/483/mohnark-pharmaceuticals-inc/721b5be7-e90a-4eca-9126-b822600444d3

> FDA 483 for Mohnark Pharmaceuticals Inc on February 25, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mohnark Pharmaceuticals Inc
- Inspection Date: 2022-02-25
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Mohnark Pharmaceuticals Inc, an OTC drug manufacturer in Davie, FL, revealed significant deficiencies across multiple areas. The firm was cited for lacking adequate quality control procedures, failing to properly test raw materials, and maintaining incomplete production records. Additionally, issues were noted regarding inadequate dust control equipment and unsuitable building construction, indicating a lack of current Good Manufacturing Practices.

## Related Officers

- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)
- [Lillian M Colon-McKnight](https://www.keypedia.com/people/lillian-m-colon-mcknight/ce6346b7-a006-4f84-afba-9fdda488042d)

Company: https://www.keypedia.com/companies/mohnark-pharmaceuticals-inc/532fdc82-afe5-47b5-b472-7a814e318377

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