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The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). BayCare Integrated Service Center, LLC |
02 Jun 2023 | Normal | Justification: Artwork management processes influence label design and information accuracy. Any failure in this process can result in non-compliant labels being produced. Excerpt: Specifically, the following information is not found on your drug product labels: a) Dosage form Examples of your drug product labels that do not contain this information:... View Details |