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A recently published 483 for a sterile manufacturer shows once again that the issue of supplier control is an ongoing concern for the US FDA. However, this is not the only focus in this report, as there are 13 other, sometimes detailed (and hair-raising) observations over 20 pages.

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More than two years ago, the FDA published a Guidance for Industry on remote evaluations: "Remote Interactive Evaluations". Now the successor has been published as a draft. Not much has changed, except for one important innovation.

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The U.S. FDA issued a Warning Letter to the US American company "ALI Pharmaceutical Manufacturing, LLC" after having inspected its site in September/October 2022.

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Due to numerous and serious GMP violations in the aseptic area, the FDA issued a Warning Letter to an Indian sterile manufacturer in October. The areas affected include media fills, employee behaviour in the aseptic area, cleanroom & equipment design, environmental monitoring and CAPA.

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The Austrian Medicines and Medical Devices Agency has entered a new GDP Non-Compliance Report into the EudraGMDP database. The authority writes that major deficiencies were detected in the quality systems of a wholesale distributor, also related to the lacking awareness of the Responsible Person. As a consequence, the Wholesale Distribution Authorisation (WDA) for human and veterinary medicinal products was withdrawn.

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FDA Warning Letters are extremely important for pharmaceutical companies. This is once again demonstrated by the case of a Swiss company that received a Warning Letter on September 11, 2023. Read more in this GMP News.

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Among other things, a Swiss pharmaceutical manufacturer received a Warning Letter from the FDA due to inadequate 100% visual inspection of its eye preparations. But the conduct of media fills and the completeness of laboratory results were criticised as well.

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The U.S. Food and Drug Administration (FDA) has sent a new Warning Letter to a manufacturer located in South Korea. The firm manufactures over-the-counter (OTC) topical drug products, such as hand sanitizers. During an inspection, significant violations of Current Good Manufacturing Practice (CGMP) were found.

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The Spanish Agency Of Medicines And Medical Devices has added a new GDP Non-Compliance Report to the EudraGMDP database. During an inspection of a wholesale distributor, a series of deviations from Good Distribution Practice were found. This led to a suspension of the company's authorisation for procuring, holding, supplying and storage by contract of human medicinal products.

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For fiscal year 2022, the FDA's dashboard lists 168 inspections at pharmaceutical companies in the EU. What is the reason for this?

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