POSTS

Post by Barbara W. Unger | August 6, 2019

Week of July 28th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

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.

Post by Barbara W. Unger | August 1, 2019

Part 1: Analysis of CY2018 FDA Warning Letters That Cite Data Integrity Failures

GMP expert Barbara W. Unger evaluates data integrity deficiencies from CY2018 and presents the trends since CY2008.

Post by Barbara W. Unger | July 30, 2019

Week of July 21st, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

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.

Post by Barbara W. Unger | July 25, 2019

Review of the Office of Generic Drugs’ 2018 Annual Report

GMP expert Barbara W. Unger reviews the Office of Generic Drugs' 2018 Annual Report.

Post by Barbara W. Unger | July 23, 2019

Week of July 14th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

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.

Post by Barbara W. Unger | July 16, 2019

Week of July 7th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

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.

Post by Barbara W. Unger | July 11, 2019

Analysis of CDER Office of Pharmaceutical Quality Report on the State of Pharmaceutical Quality

GMP expert Barbara W. Unger provides her assessment of CDER's State of Pharmaceutical Quality Report.

Post by Barbara W. Unger | July 9, 2019

Week of June 30th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

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.

Post by Barbara W. Unger | July 3, 2019

Week of June 23rd, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

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.