News

01.04.2020

EU has published a new Notice to Stakeholders on the withdrawal of the UK which summarises the most important aspects in three parts.

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Covid-19: FDA Postpones Domestic and Foreign Inspections

26.03.2020

In response to the COVID-19 outbreak, FDA has decided to postpone most foreign inspections until the end of April.

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FDA Warning Letter to Indian Manufacturer for Inadequate Testing of Incoming APIs

26.03.2020

In a Warning Letter to an Indian manufacturer, the FDA notes that the firm lacked adequate testing for incoming API and relied on the suppliers' certificates of analyses (COA) without establishing the reliability of the suppliers' analyses through appropriate validation.

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Foreign Particles in Oral Dosage Forms can also Cause Warning Letter

26.03.2020

A US-American medical manufacturer has received a Warning Letter from the FDA due to foreign particles in a solution for oral application and especially regarding the handling of this incident. Besides, further deficiencies were observed during the inspection, such as errors in the evaluation of HPLC data and data integrity in the laboratory in general.

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Lying in an Inspection? Not a good Idea!

11.03.2020

A Chinese company was placed on import alert by FDA because investigators observed significant deviations from cGMP. In some cases, the company told the untruth.

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Warning Letter: FDA criticizes Supplier Qualification

19.02.2020

Supplier Qualification and the respective contracts in outsourcing activities are always hot topics in inspections, as a recent FDA Warning Letter shows.

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Falsified Medicines: New EU Aide Memoire for GDP

18.02.2020

The European Commission has published an aide memoire for Good Distribution Practices (GDP) inspection of wholesalers’ compliance with Commission Delegated Regulation (EU) 2016/161 for safety features.

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Deficiencies in Maintenance, OOS and Data Integrity lead to Warning Letter

17.02.2020

A pharmaceutical manufacturer in India received a Warning Letter from the US-American FDA in December due to deficiencies in the areas of maintenance/cleanliness, OOS and data integrity. Read more here.

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Warning Letter for US Manufacturer: Issues in the Water System

17.02.2020

A US-American pharmaceutical manufacturer received a Warning Letter from the FDA in November 2019 due to microbial issues in the water system, deficiencies in qualification/validation and insufficient stability data. Read more here.

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Stability Testing Program as a Common Problem in recent FDA Warning Letters

05.02.2020

Stability testing of drug products is required by 21 CFR 211.166 of the cGMP guidelines. There has been an increase in GMP violations related to stability testing. A few days ago, a German company received an FDA Warning Letter in which, among others, the stability program was criticized.

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