This week, one warning letter was issued by CDER to a finished pharmaceutical manufacturer, and another was issued to a Genetech site that manufactures human cells/tissue-based products.
FDA posted four warning letters this week including one to an API manufacturer, one to a compounding pharmacy and one to a drug product manufacturer.
We compiled last week’s warning letters for you. Take a look.
Last week, the FDA issued a warning letter after a study drug was administered even though the study had been placed on clinical hold.
From poor water quality to a hush-up of failing test results, we cover five warning letters the FDA sent to companies this week.