Pharma Blog

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Pharma Blog 2018-02-26T09:29:08+00:00

PHARMA/BIOTECH

BASIC GMP, GMP Enforcement, Quality / CMC Guidance, and More…

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  • New FDA 483s

41 New FDA 483s Added | October 22nd 2018

October 22nd, 2018|

In the past week, we added the following 41 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store.

  • Changes in the FDA

How the FDA and the 483 Have Changed

October 18th, 2018|

We asked our GMP Editor in Chief 3 important questions and got 3 insightful answers. Using decades worth of professional experience, she shares both the strengths and weaknesses of this thing we call the 483.

  • Recalls

9 New Recalls | Week of October 8th 2018

October 17th, 2018|

From labels saying "you can take 4 pills" when it should really say "take 2" to injections with loose metal ferrules, here are last week’s recalls.

1210, 2018

Week of September 30th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

October 12th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, FDA Warning Letters, Medical Devices|

The FDA posted 13 warning letters this week. A collection were from the Center for Tobacco Products. There was 1 warning letter issued to a PET firm, 1 to a device firm, and 1 to a compounding pharmacy. We cover all 3 in this post.

1110, 2018

6 Features to Look for in FDA 483s

October 11th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Inspections, FDAzilla, Food, Form FDA 483, Medical Devices|

A challenge with interpreting 483s that are issued to firms other than your own is that 483s don’t provide the context for what occurred during the inspection and how the issues were identified. Thus, to evaluate the seriousness of a 483 and the potential for additional enforcement action, I ask the following questions.