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 [...]

1906, 2018

How to Do A Keyword Search in FDA Warning Letters

By | June 19th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement Trends, FDA Inspections, FDA Warning Letters, FDAzilla, Food, Form FDA 483, Medical Devices, Supplier Management|0 Comments

Want to learn how to do a keyword search in FDA warning letters? Watch the video or read the post below. We have about 15,000 warning letters in our database. You can search on any term or combination of terms in any of these documents. As an example, I’m going to search for “media fills”...