# FDA 483 - DAP Pharmaceuticals, LLC - September 11, 2019

Source: https://www.keypedia.com/records/483/dap-pharmaceuticals-llc/7bfe7efc-33d4-43a5-a35c-fa020360c7fa

> FDA 483 for DAP Pharmaceuticals, LLC on September 11, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DAP Pharmaceuticals, LLC
- Inspection Date: 2019-09-11
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations Central
- Summary: An FDA inspection of DAP Pharmaceuticals, LLC in Lake Park, FL, an API repacker, revealed significant deficiencies in its quality system. The firm failed to ensure proper stability data, identity testing, record-keeping, and established procedures for packaging and labeling materials. Additionally, issues were noted with the independence of the quality unit, employee training, and the effectiveness of cleaning and sanitization methods.

## Related Officers

- [Vivin George](https://www.keypedia.com/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)
- [Jennifer L. Huntington](https://www.keypedia.com/people/jennifer-l-huntington/c04e1c86-c7ec-4613-b3f7-a1f9ba2b2f2c)

Company: https://www.keypedia.com/companies/dap-pharmaceuticals-llc/65553b5e-2309-4fa7-ac1d-add6cda686fc

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations-central/fdd6d0ca-6039-4ac5-8989-2b0514b056f0