News

On behalf of the ECA Concept Heidelberg regularly analyses the deficiencies in FDA Warning Letters regarding medical devices. Since medical devices can be part of a combination product consisting of a medicinal product and a medical device, these statistics are also of interest to manufacturers of these products. What did the FDA criticise in the last fiscal year?

More

A pharmaceutical manufacturer of OTC products in Turkey has now received a Warning Letter from the FDA due to a number of fundamental GMP violations. The inspection had taken place in May 2024.

More

In December 2024, the U.S. FDA issued a Warning Letter on its website to the Indian company "Micro Orgo Chem" after having inspected its site in April 2024. According to the Warning Letter, the firm failed to "design a documented, on-going stability testing program to monitor the stability characteristics of API ".

More

A pharmaceutical manufacturer in China granted the FDA only limited access to documents, records and premises during an inspection in March 2024. The Warning Letter now shows that this is not a good idea.

More

At the beginning of December, it was announced in the EDQM website newsroom that the Brazilian health authority ANVISA has started to recognise evaluation reports and documents from other authorities as part of its assessments.

More

An FDA inspection is a challenging and often stressful situation for most companies. A new Warning Letter documents a case where the pressure apparently became too much to handle. The Quality Manager refused to provide documents, repeatedly interrupted and berated his own employees, and shouted at the inspectors. Despite these significant disruptions, the inspection revealed numerous GMP deficiencies.

More

Data Integrity violations and ineffective Quality systems caused a Warning Letter of the U..S FDA issued in December 2024, to the US American company "Viatris, Inc." after having inspected its Indian site "Mylan Laboratories Limited, Inc., a Viatris company" in June 2024. 

More

PIC/S has published two guidance documents for inspectors: "Guidance on Remote Assessments" and "Aide Memoire on Remote Assessments", defining and describing three types of remote assessments and one combination type.

More

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to a Chinese OTC manufacturer based on a review of records. As seen in other recent FDA Warning Letters reported in the ECA newsletters, the cited violations include issues with identity testing, specifications, stability testing, and quality unit oversight.

More

The US FDA found serious GMP violations at the facility of an Indian OTC manufacturer of sterile ophthalmic drop products. A Warning Letter has now been sent to the company.

More
x
Search