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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.

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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. 

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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.

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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.

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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.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter highlighting significant violations of Current Good Manufacturing Practice (CGMP) regulations. These violations, identified through a review of records, include insufficient component testing, inadequate quality control, and improper stability testing.

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Unfortunately, it happens again and again that pharmaceutical companies do not archive their documentation but discard it, a violation of basic GMP requirements. Now an Indian manufacturer has been caught by the FDA.

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The U.S. Food and Drug Administration (FDA) continues to conduct inspections within the European Union (EU), as highlighted by a recent Warning Letter issued to an Italian pharmaceutical manufacturer. Following the regulatory findings, the company announced a suspension of OTC production for the remainder of 2024.

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The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter to a Chinese company registered as a manufacturer of over-the-counter (OTC) drug products. This action was based on a review of records that identified deficiencies in the company’s quality control unit, laboratory testing for the drug product, and the identity testing of incoming components.

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The U.S. Food and Drug Administration (FDA) has recently published a new Warning Letter. The authority observed pest activity in the raw storage area, water leaks, and missing ceiling tiles in the drug manufacturing area. Furthermore, employees used the QC lab for non-CGMP activities, such as meal preparation and dishwashing.

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