FDAzilla Blog

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

  • Follow the Trail

Follow the Trail to Find Data Integrity Problems

July 17th, 2018|Biopharma / Pharma, Clinical, FDA Inspections, FDA Warning Letters, Form FDA 483, Medical Devices|

How Do I Follow The Trail? One of the most effective audits I ever participated in started with a systems-naive auditor asking a simple question: “Imagine I’m a sample arriving at your loading dock. What [...]

  • Food Warning Letters

FDA Sent These 4 Warning Letters for Food Companies | June 2018

July 16th, 2018|CGMP, FDA Warning Letters, Food, FSMA|

We took a snapshot of the 4 warning letters the FDA sent to food companies last [...]

  • Warning Letters

Week of July 1st 2018 | FDA Sent These Warning Letters to Pharma Companies

July 13th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters|

FDA posted 6 warning letters this week, including 1 to a finished pharma firm, 1 [...]

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 [...]

  • New FDA GMP Inspection Model

New FDA GMP Inspection Model

September 25th, 2017|Biopharma / Pharma, CGMP, FDA, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, Inspection - Features, quality assurance|

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief While the drug GMPs haven’t changed much, if at all, in recent years, the FDA is planning for significant changes in how drug GMP [...]

  • 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

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 [...]

1808, 2016

A Bad 483 Could Cost A Company Millions

August 18th, 2016|Categories: Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Consent Decree, FDA Inspections, Form FDA 483, MOST POPULAR|

“Forget about actual warning letters. The cost of us receiving a moderately bad 483 is roughly $250,000.” I heard this from a reputable Head of Manufacturing of one of the largest biopharma companies in the world.  While most pharma and med device companies seems to learn quickly from everyone else’s mistakes, companies still occasionally get a “moderately bad” 483.  And [...]

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  […]