News

The new version of the "CADIFA Manual for Administrative Procedures" of the Brazilian Health Regulatory Agency (Anvisa) was published in February 2025 and is available on its website in Portuguese and in English language.

More

After inadequate root cause analyses were repeatedly the subject of FDA Warning Letters, another one was published on this topic. This time for a global company with a site in the USA.

More

The US Food and Drug Administration (FDA) has identified serious violations of Current Good Manufacturing Practice (CGMP) regulations during a review of documents submitted by Akron Formulations India Private Limited, a manufacturer of OTC products.

More

The Supplement 11.8 to the European Pharmacopoeia (Ph.Eur.) is now available. All CEP holders (Certificate of Suitability of Monographs of the European Pharmacopoeia - holder) are required to adapt their specifications and thus the respective CEPs to comply with the new monographs by July 01, 2025.

More

A warning letter to a Chinese manufacturer of OTC drug products continues the series of FDA warning letters on the subject of inadequate testing of starting materials and components. In this case too, however, the warning letter goes beyond these deficiencies.

More

In November, the FDA issued a warning letter to a manufacturer of topical products in France. In addition to inadequate testing of components used, e.g. for ethylene or diethylene glycol, the warning letter also includes a whole series of other deviations.

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

Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. The FDA has now published the data for fiscal year 2024 (October 2023 – September 2024). As in previous years, we have conducted an evaluation regarding deficiencies in the stability program.

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

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
x
Search