483
Orca Biotech LLCOrca Biotech LLC – FDA 483, Aug 5, 2021
Record Details
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.
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- Denver District Office
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ID · 6e5e5c5e-6e00-4db2-9a95-aa965fb6f970
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