Medical Device Blog

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Medical Device Blog 2018-02-16T13:10:26+00:00


FDA Inspection Preparation, Supply Risk Management, FDA Guidance, and More…

  • FDA Sent These Warning Letters

FDA Sent These 4 Warning Letters for Medical Device Companies | Oct – Dec 2017

January 31st, 2018|0 Comments

We took a snapshot of the 4 warning letters the FDA sent to medical device companies last quarter.  Device manufacturing violations ranged from failing to evaluate complaints to failing to establish [...]

If You Didn’t Document It, It Didn’t Happen

January 25th, 2018|0 Comments

A Guest Post from Oliver Yu, CTO, FDAzilla A core belief of drug manufacturing is that the drug alone is not the product of the pharmaceutical company.  The drug and the documentation proving that the [...]

  • US-EU Mutual Recognition Agreement of 2017

US-EU Mutual Recognition Agreement of 2017

August 22nd, 2017|0 Comments

A Long Time in the Works by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief Implementation of the Mutual Recognition Agreement (MRA) for drug GMP inspections between the [...]

1210, 2018

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

By | October 12th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, FDA Warning Letters, Medical Devices|0 Comments

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

By | October 11th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Inspections, FDAzilla, Food, Form FDA 483, Medical Devices|0 Comments

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.