Karriere
Kom med på holdet

Novel / Recurring deficiencies causing a FDA Warning Letter.

Del denne side:

John Lee, Video 4 of 9

This 4th video (out of 9 in total) focuses on novel and / or recurring deficiencies causing a FDA Warning Letter.

The video focuses on 3 deficiencies specifically, i.e.:

1. Contract Agreement – Quality Agreements:

2019 shows, that FDA has a continued strong focus on contract arrangements. This is seen in the Warning Letters issued to Contractors (Contract Manufacturers, Contract Packagers, Contract Laboratory), but also Contract Givers.
FDA is aware of, that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers and labellers. FDA regards contractors as extensions of the manufacturer.
In 2019, Warning Letters were also issued to Contract Givers. As Contract Giver (Product Owner), you are fully responsible for the quality of your drugs regardless of agreements in place with your contract facilities.

2. Raw Materials:

Raw materials supplier control is recurring issue. You must observe your suppliers’ regulatory status prior to purchasing. Who is in fact the original manufacturer? You have a pedigree responsibility.

3. Common equipment to produce non-drug product:

Common Facilities used for drug and non-drug product.

 

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

Risk Assessment, FDA DRUG GMP

John Lee, Video 7 of 9

Topledelser sætter kvalitet øverst på agendaen

Kvalitet og compliance var nok ikke tidligere et begreb som trak overskrifter, og typisk blot en stabsfunktion under...

FDA Inspections during COVID-19 pandemic

John Lee, Video 1 of 9