FDA posted five warning letters this week although none are drug or device GMP warning letters. However, two warning letters that we cover here were identified as posted on July 23rd. For any of you who also follow warning letters closely, be cautious about putting too much faith in FDA’s posting dates for the warning letters.
GMP expert Barbara W. Unger evaluates data integrity deficiencies from CY2018 and presents the trends since CY2008.
We cover three GMP drug warning letters and a warning letter to a large CBD firm for misbranding and distribution of the unapproved new drug. FDA did not agree with the firm’s statement that the product was a dietary supplement.
GMP expert Barbara W. Unger reviews the Office of Generic Drugs' 2018 Annual Report.
FDA published three drug warning letters this week, one of which was issued in April and one that found a firm to be shredding GMP documents.
There were six warning letter postings during this week, including one regarding Akorn's site in Somerset, NJ that the company announced a few weeks ago.
GMP expert Barbara W. Unger provides her assessment of CDER's State of Pharmaceutical Quality Report.
A surprisingly busy week for enforcement considering the federal holiday. Warning letter enforcement includes five drug warning letters published this week, two of which were sent to API re-packagers, and one to a compounding pharmacy.
Three warning letters were posted this week: two for drugs and one for device GMP violations. Akorn also announced that they received a warning letter but it has not yet been published.