Medical Device Blog

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

MEDICAL DEVICES

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  • 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 [...]

2202, 2018

5 Ways Manufacturing Quality Problems Can Take Down a Company

By | February 22nd, 2018|Categories: Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA, FDA Enforcement Trends, FDA Inspections, FDA Warning Letters, FDA-Regulated Industry, Food, Form FDA 483, Medical Devices|0 Comments

Manufacturing quality issues arise from time to time at [...]

1902, 2018

GMP Regulatory Newsletter: Summary Scan | Week of 2/11/18

By | February 19th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement Trends, FDA Inspections, FDAzilla, Medical Devices|0 Comments

Laws, Regulations, Guidance, and Concept Papers The week of [...]

902, 2018

The Ultimate Guide to Researching Your FDA Inspector

By | February 9th, 2018|Categories: Biopharma / Pharma, CGMP, FDA, FDA Enforcement Trends, FDA Inspections, FDA-Regulated Industry, FDAzilla, Food, FSMA, Inspection - Features, Medical Devices, Pharma - Featured|0 Comments

The trick with any FDA [...]

702, 2018

20,000 FDA Warning Letters

By | February 7th, 2018|Categories: Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Warning Letters, FDA-Regulated Industry, FDAzilla, Food, Medical Devices|0 Comments

Here at FDAzilla, we’re excited to report that we have [...]

1310, 2017

FDA Issued 36 Product Recalls, Import Alerts, and Consent Decrees in September 2017

By | October 13th, 2017|Categories: Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Consent Decree, FDA Enforcement News, FDA Inspections, FDAzilla, Medical Devices|0 Comments

Here’s our monthly summary of product recalls, import alerts, consent [...]