FDA posted 7 warning letters this week including 2 warning letters to Medtronic regarding non-conformance that resulted in a Class I recall of a defibrillator earlier in 2018. In addition, warning letters were issued to 1 firm in Canada and 1 firm in China. And, in the largest coordinated enforcement effort in the FDA’s history, 1,300 warning letters were issued to a single industry.
When site personnel complete subjects’ e-diaries, bad things happen. Don’t let them happen to your company! This post explains the top 3 steps to avoid a costly ePRO 483.
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 [...]
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 [...]
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.
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 [...]
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 [...]
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 […]