483
Traditional Medicinals, IncTraditional Medicinals, Inc – FDA 483, Apr 12, 2018
Record Details
An FDA inspection of Traditional Medicinals Inc., a dietary supplement manufacturer in Sebastopol, revealed significant deficiencies in their quality control documentation. The firm failed to establish complete product specifications, theoretical yields in master manufacturing records, and cross-references for tests and examinations. Additionally, batch production records lacked essential information regarding equipment maintenance.
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ID · 5a7a1ecd-7208-4baa-82e7-2040f7687040
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