# FDA 483 - Orca Biotech LLC - August 05, 2021

Source: https://www.globalkeysolutions.net/records/483/orca-biotech-llc/6e5e5c5e-6e00-4db2-9a95-aa965fb6f970

> FDA 483 for Orca Biotech LLC on August 05, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Orca Biotech LLC
- Inspection Date: 2021-08-05
- Product Type: biologics
- Office Name: Denver District Office
- Summary: An FDA inspection of Orca Biotech LLC in Sandy, UT, a biological drug own-label distributor, revealed significant deficiencies. The firm failed to establish complete master production and control records, lacked strict control over drug product labeling operations, and did not adequately handle customer complaints. These issues indicate a lack of robust quality control and regulatory compliance for their distributed biological drug products.

## Related Officers

- [Scott T. Ballard](https://www.globalkeysolutions.net/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)

Company: https://www.globalkeysolutions.net/companies/orca-biotech-llc/9ad80eaf-fa9e-48df-a289-b0b795386fc0

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face