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Post by Barbara W. Unger | September 24, 2019

Week of September 15th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Enforcement included only two warning letters this week: we cover one BIMO warning letter and one issued to an OTC drug firm.  The OTC firms continue to show that they have a limited grasp of the fundamentals of GMPs required for their product type. Also, Lupin announced that they received a warning letter but FDA has not yet published it.