FDAzilla Blog

FDAzilla Blog
FDAzilla Blog 2018-06-25T10:08:28+00:00

  • Warning Letters

Week of September 9th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

September 21st, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, FDA Warning Letters, Medical Devices|

FDA posted 7 warning letters this week including 2 warning letters to Medtronic regarding non-conformance that resulted in a Class I recall of a defibrillator earlier in 2018. In addition, warning letters were issued to 1 firm in Canada and 1 firm in China. And, in the largest coordinated enforcement effort in the FDA’s history, 1,300 warning letters were issued to a single industry.

  • ePRO Data

The Top 3 Actions You Can Take to Protect Your Company’s ePRO Data

September 19th, 2018|Biopharma / Pharma, Clinical, FDA Enforcement Trends, FDA Inspections, Form FDA 483, Medical Devices|

When site personnel complete subjects’ e-diaries, bad things happen. Don’t let them happen to your company! This post explains the top 3 steps to avoid a costly ePRO 483.

  • New FDA 483s

74 New FDA 483s Added | September 17th 2018

September 17th, 2018|Biopharma / Pharma, Food, Form FDA 483, Medical Devices, Weekly FDA 483s|

In the past 2 weeks, we added the following 74 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store.

Pharma Blog

PHARMA/BIOTECH

  • Expert Guidance from Barb Unger
  • FDA Guidance
  • Tips on Supplier Management
  • More…
Read the Pharma/Biotech Blog
Medical Device Blog

MEDICAL DEVICE

  • Warning Letters
  • FDA Guidance
  • Data Integrity
  • More…
Read the Medical Device Blog
Food Blog

FOOD

  • FSMA
  • Inspection Prep
  • Tips on Supplier Management
  • More…
Read the Food Blog

INSPECTION PREPARATION

  • The Ultimate Guide to Researching Your FDA Inspector

The Ultimate Guide to Researching Your FDA Inspector

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

The trick with any FDA inspection preparedness program is to reduce the risk of surprise by understanding FDA history and tendencies. But like most professionals in this industry, you’re probably [...]

  • 10 Ways to Prepare for a GMP Inspection

10 Ways to Prepare for a GMP Inspection

January 26th, 2017|CGMP, FDA Inspections, FDAzilla, Inspection - Features|

How to Prepare for a GMP Inspection for Small and Virtual Companies by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief Preparing for GMP inspections, particularly pre-approval inspections, can be a challenge when [...]

POPULAR POSTS

2208, 2018

A Bad 483 Could Cost a Company Millions

August 22nd, 2018|Categories: Biopharma / Pharma, CGMP, FDA Inspection Stories, FDA Inspections, FDA Warning Letters, Food, Form FDA 483, Medical Devices, MOST POPULAR|

I spoke to a former VP of quality at the PDA/FDA Joint Regulatory Conference. He said one of his bad 483s probably cost him $5 million. And that’s cheap – that’s just a 483. What about a warning letter? There is an even greater magnitude of reputation damage, impact on new drug approvals, etc. This post describes the full scope and includes articles/case studies.

2011, 2017

Deep Pockets | Does the FDA Get Tougher if the Owner Gets Richer?

November 20th, 2017|Categories: Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement Trends, FDA-Regulated Industry, FDAzilla, Form FDA 483, MOST POPULAR, Pharma - Featured|

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief Acquisition of one pharmaceutical firm by another is preceded by due diligence efforts in many functional areas.  Let’s talk about activities in the GMP area.  Firms may not be able to fully rely on past inspections by the FDA to predict the extent of remediation that might be [...]

3004, 2016

Does an FDA Import Alert automatically equate to an impending FDA Warning Letter?

April 30th, 2016|Categories: Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, FDA Warning Letters, Medical Devices, MOST POPULAR|

by Barbara Unger, FDAzilla GMP Quality Expert INDIA | IMPORT ALERT 66-40 and Association with Warning Letters Regarding These Sites | Detention Without Physical Examination of Drugs from Firms Which Have Not Met Drug GMPs  […]