FDAzilla Blog

FDAzilla Blog
FDAzilla Blog2019-02-08T15:47:35-05:00

  • WWL031019 finished

Week of March 10th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

March 19th, 2019|Biopharma / Pharma, CGMP, Clinical, FDA, FDA Warning Letters, FDAzilla, quality assurance|

Warning letters posted this week include ones demonstrating FDA’s continued focus on over-the-counter (OTC) product manufacturers and manufacturers in India, including a particularly testy letter to Pfizer for a Hospira site in India that they are closing.

Pharma Blog


  • Expert Guidance from Barb Unger
  • FDA Guidance
  • Tips on Supplier Management
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Medical Device Blog


  • Warning Letters
  • FDA Guidance
  • Data Integrity
  • More…
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Food Blog


  • FSMA
  • Inspection Prep
  • Tips on Supplier Management
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  • A New FDA Model

The New FDA GMP Inspection Model

August 13th, 2018|483 Crash Course, Biopharma / Pharma, CGMP, FDA, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, Inspection - Features, Medical Devices|

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 inspections are scheduled and conducted. Last year, the FDA made available a description of their new operating model that will ensure integration of review and inspection activities for human drugs. This post dives deep into this model – including new timelines for those of us in the drug industry.

  • 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 [...]


2208, 2018

A Bad 483 Could Cost a Company Millions

August 22nd, 2018|Categories: 483 Crash Course, 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  […]