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There has been a recent accumulation of Warning Letters from the U.S. Food and Drug Administration (FDA) to manufactures of hand sanitizer products. At the end of November, a further letter was published. In this case, FDA laboratory analyses showed that the ethanol content of several batches was too low. In addition, the FDA has also found numerous GMP violations. There was already a lack of the necessary basic SOPs.

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Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. The FDA has now published the data for the fiscal year 2022. Deficiencies in the stability programme in the area of "drugs" were mentioned in numerous FDA 483 forms.

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Some authorities within the PIC/S want to mutually recognise GMP inspection reports in order to avoid duplication of work. There is now a corresponding statement on this.

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Just recently, we reported on a Warning Letter to an American manufacturer of hand sanitizer drug products. Now another Warning Letter has been published by the U.S. Food and Drug Administration (FDA), also addressed to such products. In this case, it is about a drug manufacturer located in Puerto Rico. In addition to formal GMP violations and inadequate analytical testing, the FDA also criticizes the overall condition of the production facility.

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In a Warning Letter to a US manufacturer, the FDA criticises investigations after deviations in the media fill. Also, derived CAPA measures did not go far enough for the FDA.

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The analysis of the Warning Letters sent out in fiscal year 2022 offers a revealing overview of what FDA inspectors find when they visit the production facilities of medicinal product manufacturers. Read more about the "Top Ten" GMP violations.

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In a blog post, the UK MHRA comments on the resumption of international GMP inspections and the validity of expired GMP certificates.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a U.S. manufacturer. Therein, the FDA once again highlights the importance of analytical testing of incoming raw materials, finished drug product testing and stability testing. In the case in question, a manufacturer of OTC drug products had been found to have significant deficiencies in these areas.

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The U.S. Food and Drug Administration (FDA) has issued Warning Letters to Amazon and Walmart. Laboratory analyses showed that both companies sold products that contained diclofenac, which was not listed on the product labels. The FDA sees this as a potential health risk for consumers.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Chinese manufacturer. The FDA blames the company in question for a whole series of GMP violations, including to identity testing, cleaning and maintenance of equipment, microbial testing and QU oversight.

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