Karriere
Kom med på holdet

FDA-483 observations and warning letter citations 2019 – 2020

Del denne side:

John Lee, Video 2 of 9

This 2nd video (out of 9 in total) focuses on FDA Form 483 observations and Warning Letters, overall statistics for 2019 (and partly 2020) for Drug GMP.

Here you will find, a 9% increase in number of FDA-483's in 2019 compared to 2018. In absolute numbers, 779 FDA-483’s in 2019 as compared to 716 in 2018.

Top 3 issues in FDA-483’s are in 2019 (still) violation of CFR,
• 211.22(d), Quality Assurance Oversight
• 211.192, Investigations
• 211.160(b), Laboratory Control

98 Warning Letters were issued in 2019. That is an 8% increase compared to 2018. As per August 2020, 66 Warning Letters are issued.

Top 3 issues in FDA Warning Letters are,
• Validation
• QA Oversight
• Laboratory Controls

 

In general, you can access FDA's Inspection Citation database. It covers general citations, e.g. Drug, Device and Part 11 Compliance: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-citation

 

 

 

The video is recorded during the COVID-19 US lock-down by John Lee with mobile recording equipment, and the quality could be better. Focus on the great presentation and content instead.

The statistics can be downloaded as an E-book:

Læs mere

Hvis du vil høre mere om hvordan Genau & More kan hjælpe dit firma, så kontakt

Henrik Johanning

CEO & seniorkonsulent
IT & Automation / GAMP, Regulatory Affairs, Project Management, Management Consulting, GMP, Træning

Genau Shares

Sommerferie-hilsen

Rigtig god sommer!

Kvalitet og tillid sat i system

For vores medarbejdere og klienter er det selvfølgelig afgørende, at de kan have tillid til os som arbejdsgiver og tæt...

Trends. FDA Drug GMP versus EU Grug GMP

John Lee, Video 5 of 9