News

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 As a consequence, the Wholesale Distribution Authorisation (WDA) for human and veterinary medicinal products was withdrawn.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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The U.S. Food and Drug Administration (FDA) has issued three somewhat similar Warning Letters. The companies concerned had each failed to respond to requests for records and other information.

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The FDA has published a new guidance document on the possible use of alternative methods in the preparation of inspections or in place of inspections for marketing authorisation applications that are still pending.

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The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a U.S. OTC manufacturer. During an inspection, several CGMP violations were found.

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