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FDA Sends Warning Letter To Contract Filler

Violations of CGMP in sun care and OTC topical product manufacturing.

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By: Christine Esposito

Editor-in-Chief

The US Food & Drug Administration (FDA) sent a warning letter on Dec. 17, 2019 to Cross Brands Contract Filling, LLC, Rockledge, FL, following an inspection conducted at its facility in June 2019. The warning letter summarizes what FDA calls “significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.”   During the inspection, an FDA investigator observed specific violations including, failure to conduct at ...

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