FINAL Part 3: Who’s Who? Seeing CROs Clearly.
Clinical service provider or CRO? Observations of FDA enforcement.
23 New FDA 483s Added | December 10th 2018
In the past week, we added 23 483s to our database of 27,500+ FDA inspection documents.
Week of November 25th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies
Last week, the FDA issued a warning letter after a study drug was administered even though the study had been placed on clinical hold.
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 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
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 […]