Skip to main content Skip to search Skip to main navigation

FDA: Domestic routine inspections postponed due to Covid-19

The US FDA had already announced on 10 March 2020 that most foreign inspections would be postponed until April with immediate effect. Now domestic routine surveillance inspections will also be scaled back.

However, the FDA will respond to public health emergencies involving FDA-regulated products. Furthermore, domestic for-cause inspection assignments are evaluated and proceed in cases where decisions are mission-critical. During this interim period, other ways to conduct inspectional work will be explored, such as evaluating records instead of on-site inspections. The FDA calls upon the responsibility of manufacturers to produce reliable quality products according to cGMP requirements.


Source:

FDA: Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

You may also be Interested in the Following Articles:

EU: Agreement on the Pharmaceutical Package

EU: Agreement on the Pharmaceutical Package

On 11 December, the European Commission, the European Parliament, and the Council of the European Union reached a provisional agreement to update Europe's medicinal products regulatory framework.

Read more
EMA: Updated Q&As for Biological Medicinal Products

EMA: Updated Q&As for Biological Medicinal Products

EMA has updated its Q&A on biological medicinal products, addressing topics that previously required clarification or were subject to differing interpretation. The latest revision adds six new questions and updates several existing answers.

Read more
ICH: New Recommendations for the Manufacture of ATMPs

ICH: New Recommendations for the Manufacture of ATMPs

The ICH’s Cell and Gene Therapy Discussion Group (CGTDG), which was established in May 2023, has provided recommendations with regard to future Advanced Therapy Medicinal Products (ATMPs) Related Guidelines.

Read more
GMP Publishing Embarks on a new Digital Chapter

GMP Publishing Embarks on a new Digital Chapter

After months of intensive work, creative ideas, and technical finesse, the time has finally come: the GMP Verlag website has been given a fresh new look.
Read more
 Basics on the Integrity of Container Closure Systems

Basics on the Integrity of Container Closure Systems

The integrity of a primary packaging system (container closure system) is essential to prevent product loss by leakage or evaporation and at the same time protect the product from contamination. The task of a primary packaging system (container closure system) is essentially to prevent the product from being lost (e.g. leakage, evaporation, etc.) and to prevent the product from being contaminated from the outside.

Read more
What should be considered in risk assessment?

What should be considered in risk assessment?

You can view the answer here:
Read more
Previous
Next