Data Integrity Trends in 483s and Warning Letters: Part 1
Did you know that “data integrity” is the second most-cited keyword in CDER warning letters? Or that it ranks 33rd of 483 cited keywords?
Week of May 5th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies
Enforcement was light this week, including a single warning letter to a drug manufacturer in France. We cover it here.
March 2019 | New FDA 483s
In March of 2019, we added 216 483s to our database of 27,500+ FDA inspection documents.
PHARMA/BIOTECH
- Expert Guidance from Barb Unger
- FDA Guidance
- Tips on Supplier Management
- More…
MEDICAL DEVICE
- Warning Letters
- FDA Guidance
- Data Integrity
- More…
FOOD
- FSMA
- Inspection Prep
- Tips on Supplier Management
- More…
INSPECTION PREPARATION
The New FDA GMP Inspection Model
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 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
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
The Ultimate Guide to Form FDA 483s
We put together the ultimate guide that will give you an industry primer for everything you need to know about Form FDA 483s.
A Bad 483 Could Cost a Company Millions
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.
FSMA Has Arrived – Here’s What We Know So Far
Since the introduction of FSMA in 2011, the FDA issued new guidance to the Food Industry for GMP and HARPC (Hazard Analysis and Risk-Based Preventive Controls). This guidance was encapsulated in 21 CFR 117, which is slated to replace 21 CFR 110. The biggest difference in 21 CFR 110 and 21 CFR 117 is [...]
Deep Pockets | Does the FDA Get Tougher if the Owner Gets Richer?
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 [...]
Does an FDA Import Alert automatically equate to an impending FDA Warning Letter?
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 […]