POSTS

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.

Post by Barbara W. Unger | June 25, 2019

Week of June 17th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Unlike last week, warning letter enforcement is sparse this week with only one drug GMP warning letter, none to compounding pharmacies and none to device firms.

Post by Barbara W. Unger | June 18, 2019

Week of June 10th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

This was a busy week in contrast to the past two weeks in terms of posted warning letters.  Seven drug warning letters and one device warning letter were posted.

Post by Barbara W. Unger | June 13, 2019

10 Ways for Small and Virtual Companies to Prepare for a GMP Inspection

Preparing for GMP inspections, particularly pre-approval inspections, can be a challenge when resources are limited and staff may have little expertise in these important activities.

Post by Barbara W. Unger | June 11, 2019

Week of June 3rd, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Two warning letters were issued last week to drug manufacturers. Both cite Quality Unit failures.

Post by Barbara W. Unger | June 4, 2019

Week of May 26th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Enforcement this week saw a single untitled letter to a stem cell facility (and 50-plus affiliates) and a warning letter to a compounding pharmacy.