# FDA 483 - Freelance Formulations LLC - February 08, 2023

Source: https://www.keypedia.com/records/483/freelance-formulations-llc/d1bc7b83-d8cb-422a-ab9e-351ad48da78a

> FDA 483 for Freelance Formulations LLC on February 08, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Freelance Formulations LLC
- Inspection Date: 2023-02-08
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Freelance Formulations LLC, a drug manufacturer in Bartow, FL, was cited for significant deficiencies in its quality control unit, manufacturing process validation, and material control. The firm failed to adequately approve and reject materials, validate critical processes like mixing and cleaning, and ensure proper environmental conditions, leading to the use of contaminated water in an OTC drug product. Additionally, the company relied solely on supplier certificates of analysis without performing identity testing or validating supplier reliability.

## Related Officers

- [Pharmaceutical Investigator](https://www.keypedia.com/people/kayla-v-sprague/154cb543-111b-4ad1-b45b-43900df71b90)

Company: https://www.keypedia.com/companies/freelance-formulations-llc/46cbbfd7-d21a-4033-b210-2a7c8d44cacf

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