# FDA 483 - Omega Laboratories Ltd. - January 17, 2024

Source: https://www.keypedia.com/records/483/omega-laboratories-ltd/ed69f06b-11d6-4e89-b9fb-d74be81ecc87

> FDA 483 for Omega Laboratories Ltd. on January 17, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Omega Laboratories Ltd.
- Inspection Date: 2024-01-17
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Omega Laboratories Ltd. in Montreal revealed significant deficiencies in aseptic processing controls. Observations included equipment design flaws that compromised sterility during vial filling and a lack of proper disinfection after operator contact during critical setup and interventions. These issues raise concerns about the safety and purity of sterile drug products manufactured at the facility.

## Related Documents

- [483 - 2024-01-17](https://www.keypedia.com/records/483/omega-laboratories-ltd/1f841f78-62f0-4d86-a029-26e830b3c8bf)

## Related Officers

- [Investigator](https://www.keypedia.com/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)

Company: https://www.keypedia.com/companies/omega-laboratories-ltd/79ded706-b117-405b-bd4c-4d672692c341

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1