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In a recent Warning Letter, the U.S. Food and Drug Administration (FDA) highlights several GMP violations resulting from inadequate analytical testing, missing stability and validation data, and incomplete batch documentation.

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Update EU/US MRA: EU can now also rely on FDA third-country inspections. This can be found in the updated Q&A document.

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The FDA is currently citing significant deficiencies in root cause analysis, CAPA implementation and monitoring by the quality assurance unit (QU) with increasing frequency. This is also the case in a recent Warning Letter to a company in the USA.

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The U.S. Food and Drug Administration (FDA) issued a Warning Letter to a drug manufacturing facility in California. Inspectors identified inadequate investigations and CAPA management, missing identity testing for high-risk raw materials, and unvalidated manufacturing processes. The FDA also noted serious deficiencies in laboratory controls and overall quality oversight.

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In October 2025, the U.S. FDA issued a Warning Letter (WL) to the US American company "Dixon Investments Inc. dba ARI" after having inspected its site in March 2025. According to U.S. FDA Warning Letter, the firm failed to follow their stability procedures and test an adequate amount of their finished dosage forms.

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It is important to understand that (quality) risk management is essential to the implementation and maintenance of Data Integrity concepts. In order to control the risks they need to be categorized. Such a categorization must be simple and easy to be applied fast, consistently and reliably.

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Two new Non-Compliance Reports issued by the National Authority of Medicines and Medical Devices of Romania (NAMMDR) are currently available in the EudraGMDP database. Both concern wholesale distributors whose activities were fully suspended due to violations of GDP requirements.

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In late September 2025, the FDA published a new Warning Letter describing significant deficiencies at an OTC drug manufacturer. Inspectors identified critical issues related to data integrity, OOS investigations, stability testing, process validation, and quality oversight.

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The U.S. FDA issued now a Warning Letter (WL) to a South Korean company after having inspected its site in November 2024. According to U.S. FDA Warning Letter, the firm failed to do "adequate investigations of recurring complaints" related to their finished products' packaging materials, even so these complaints occurred more than one time.

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The question we want to explore is whether Data Integrity is a completely new approach or just a different perspective on already existing GMP requirements as those arising from ICH Q7.

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