# FDA 483 - Hybrid Pharma LLC - November 09, 2023

Source: https://www.keypedia.com/records/483/hybrid-pharma-llc/d260439c-a40b-448d-8aa6-2a6123db72c8

> FDA 483 for Hybrid Pharma LLC on November 09, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hybrid Pharma LLC
- Inspection Date: 2023-11-09
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Hybrid Pharma LLC, an outsourcing facility in Deerfield Beach, FL, revealed significant deficiencies in aseptic processing, laboratory controls, and record-keeping. Observations included contaminated HEPA filters, inadequate media fill simulations, unvalidated test methods, and the compounding of drug substances on the Category 2 list. Many of these issues were repeat observations from previous inspections, indicating persistent non-compliance.

## Related Documents

- [483 - 2019-06-20](https://www.keypedia.com/records/483/hybrid-pharma-llc/789b58b7-aef6-4f74-8417-631b43204e12)

## Related Officers

- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)

Company: https://www.keypedia.com/companies/hybrid-pharma-llc/c98f645e-a540-466e-bf3b-4b6b205cb5da

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