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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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In September 2024, the U.S. FDA issued a Warning Letter to the Indian company "MMC Healthcare Ltd." after having inspected its site in March 2024. According to the Warning Letter, the firm failed to have "appropriate controls to assure the integrity of electronic test data, such as an audit trail and defined user access levels".

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The U.S. Food and Drug Administration (FDA) has issued a new Warning Letter highlighting critical violations of Current Good Manufacturing Practice (CGMP) regulations, which cover the manufacturing and analytical testing of drug products.

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In a Warning Letter to a manufacturer of non-sterile drugs in the USA, the FDA summarises a whole series of deficiencies. Serious deficiencies were found both in microbiological control and deviation handling as well as in analytics.

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