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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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?

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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 ".

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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.

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