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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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The FDA inspected a production facility of a US medical gas manufacturer in Pennsylvania (USA) in March 2024 and identified significant GMP violations.

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In an unusually extensive Warning Letter to a Canadian manufacturer, the FDA lists a large number of deficiencies and violations, ranging from a lack of analysis of raw materials and the end product to illegal statements in the product description.

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The FDA is announcing a program to enhance FDA's understanding of pharmaceutical manufacturing processes, innovations, and industry challenges. The program relies on pharmaceutical manufacturers, who host FDA staff at their facilities.

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In April 2024, the FDA inspected the production facility of a manufacturer in Gujarat, India. Due to several serious GMP violations, the authority has now issued a Warning Letter.

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We recently reported on the issuance of two FDA Warning Letters, which included observations on inadequate root cause analysis (RCA).  However, also in other Warning Letters issued, insufficient root cause analysis is cited and seems to be a frequent finding in FDA inspections.

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