FDA Warning Letters | FDAZILLA BLOG

Why Did McKesson Receive the First Warning Letter?

FDA issues the first warning letter citing failure to comply with requirements of the Drug Supply Chain Security Act (DSCSA) amendments to the FD&C Act.

By Barbara W. Unger|2019-02-18T15:52:23+00:00February 15th, 2019|Biopharma / Pharma, FDA, FDA Enforcement News, FDA Warning Letters, FDAzilla, Form FDA 483|

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

This week there were three warning letters, all for drug GMP failures. Each company was placed on import alert.

By Barbara W. Unger|2019-02-14T09:11:03+00:00February 14th, 2019|Biopharma / Pharma, CGMP, FDA, FDA Warning Letters, FDAzilla, Medical Devices|

Week of January 27th 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Now that the government shutdown is over, at least for 3 weeks, FDA has started publishing warning letters. We have two from this week.

By Barbara W. Unger|2019-02-07T14:00:01+00:00February 7th, 2019|Biopharma / Pharma, CGMP, FDA Warning Letters, FDAzilla, Medical Devices|

Week of January 6th 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

No warning letters were posted this week due to the partial government shutdown. However, there was one warning letter that posted elsewhere.

By Barbara W. Unger|2019-01-24T10:34:27+00:00January 24th, 2019|Biopharma / Pharma, CGMP, Clinical, FDA, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters, FDAzilla, Medical Devices|

Just Issued Recalls, 483s, Laws, & Warning Letters | December 2018

An efficient summary of all things FDA/GMP related for December 2018. Warning letters, refusals of inspections, new guidance, etc. See the rundown.

By Barbara W. Unger|2019-01-10T11:03:18+00:00January 10th, 2019|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Inspections, FDA Warning Letters, Form FDA 483, Medical Devices|

FDA Sent These 2 Warning Letters for Food Companies | November 2018

FDA sent 2 warning letters to food companies in November. Violations included adulterated beef and kratom contaminated with salmonella.

By Patty Harvey|2019-01-04T11:20:53+00:00January 4th, 2019|CGMP, FDA Inspections, FDA Warning Letters, FDAzilla, Food, FSMA|

Week of December 16th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

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.