Now that the government shutdown is over, at least for 3 weeks, FDA has started publishing warning letters. We have two from this week.
No warning letters were posted this week due to the partial government shutdown. However, there was one warning letter that posted elsewhere.
An efficient summary of all things FDA/GMP related for December 2018. Warning letters, refusals of inspections, new guidance, etc. See the rundown.
FDA sent 2 warning letters to food companies in November. Violations included adulterated beef and kratom contaminated with salmonella.
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.