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Pharmaceuticals / Inspections and Audits

FDA Warns California Drugmaker for Testing Deficiencies, Missing Quality Unit

July 23, 2018
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The FDA issued a warning to bB Biochem Laboratories for unsupported product expiration dates, a failure to test incoming raw materials and for having no quality unit.

An inspection of the drugmaker’s Irvine, California facility in December revealed that it released OTC drug products — two types of medicated pain relieving oil — without properly testing the identity and strength of their active ingredients.

“Unless you test each batch, you do not know whether it conforms to finished product specifications and is suitable for release,” the agency said.

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