# FDA 483 - OMEZA LLC - July 28, 2023

Source: https://www.globalkeysolutions.net/records/483/omeza-llc/64d6f9d8-923b-4f82-bb57-152913ace1eb

> FDA 483 for OMEZA LLC on July 28, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OMEZA LLC
- Inspection Date: 2023-07-28
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of OMEZA LLC in Sarasota, FL, a drug manufacturer, revealed significant deficiencies across multiple systems. Observations included unsanitary facility conditions with mold, pests, and structural issues, as well as failures in equipment cleaning procedures. The firm also lacked adequate testing for active ingredients in finished products, stability data for OTC drugs, and proper identity testing for incoming raw materials, indicating a broad lack of quality control.

## Related Documents

- [WARNING_LETTER - 2023-07-28](https://www.globalkeysolutions.net/records/warning_letter/omeza-llc/b5f17c15-076e-4811-bf0d-58baab985767)

## Related Officers

- [Pamela N. Agaba](https://www.globalkeysolutions.net/people/pamela-n-agaba/1ad981d6-8074-4572-8648-7d35f41e94f6)
- [Pharmaceutical Investigator](https://www.globalkeysolutions.net/people/kayla-v-sprague/154cb543-111b-4ad1-b45b-43900df71b90)

Company: https://www.globalkeysolutions.net/companies/omeza-llc/1856ba0f-7dc8-44d7-8b1c-15c58c978030

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