FDAzilla Blog

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

  • Warning Letters

Week of August 5th 2018 | FDA Sent These Warning Letters to Pharma Companies

August 17th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Warning Letters|

This week the FDA published 4 warning letters (3 to seafood companies and 1 to an API manufacturer - Les Produits Chimiques B.G.R. Inc).  We cover the latter below.

  • FDA NASDA

NASDA and FDA Work Together to Implement the Produce Safety Rule

August 16th, 2018|CGMP, FDA Enforcement News, Food, Form FDA 483, FSMA|

Scott Gottlieb summarized the latest work the FDA is doing to implement the Produce Safety Rule (mandated by FSMA) in a letter addressed to NASDA. FDA and NASDA have worked toward ensuring objectivity and consistency for produce inspections. They have also been working on alternatives to the traditional 483 inspectional observation form. See the complete run-through of this crucial letter for the food industry.

  • Food Warning Letters

FDA Sent These 6 Warning Letters for Food Companies | July 2018

August 15th, 2018|CGMP, FDA Inspections, FDA Warning Letters, Food, FSMA|

We took a snapshot of the 6 warning letters the FDA sent to food companies last month. Food violations ranged from failing to implement sanitation controls to failing to have an HACCP plan.

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

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  […]