FDAzilla Blog

FDAzilla Blog
FDAzilla Blog 2018-02-20T09:29:05+00:00

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

RECENT POSTS

  • FDA Sent These Warning Letters

Week of Apr 8th 2018 | FDA Sent These Warning Letters to Pharma Companies

April 20th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Warning Letters, FDAzilla|

FDA posted 10 warning letters this week: Several for misbranded drugs 2 in the drug area: 1 for a finished drug manufacturer 1 for a compounding pharmacy Note the FDA ‘requests’ that the firm [...]

  • A Look Into the Foreign Food Facility Inspection Program

A Look Into the Foreign Food Facility Inspection Program

April 19th, 2018|cGMP Quality Assurance and FDA 483s, FDAzilla, Food, FSMA|

Due to a recent push by the FDA for more foreign food inspections, it is [...]

  • GMP Regulatory Newsletter: Summary Scan

GMP Regulatory Newsletter: Summary Scan | Week of 4/8/18

April 16th, 2018|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters, FDAzilla, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers A bit of a busier week than last week [...]

  • New Featured FDA 483s

93 New FDA 483s | April 12th 2018

April 12th, 2018|Biopharma / Pharma, FDAzilla, Food, Form FDA 483, Medical Devices, Weekly FDA 483s|

In the past 2 weeks we added the following 483s to our database of 11,000+ [...]

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  […]