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The U.S. Food and Drug Administration (FDA) has issued another Warning Letter to a Chinese manufacturer regarding significant violations of cGMP regulations for finished pharmaceuticals, based on a review of records.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Chinese manufacturer regarding significant violations of cGMP regulations for finished pharmaceuticals. The firm failed to conduct proper analytical testing of incoming API lots and relied solely on supplier COAs without verifying the information. Additionally, there was a lack of documentation for the stability program.

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In January 2024, the U.S. FDA issued a Warning Letter (WL) to the Mexican company "Glicerinas Industriales, S.A. de C.V." after having inspected its site in May 2023. According to U.S. FDA Warning Letter, the firm failed to do adequate investigations on observed contamination of particles in numerous packaged drugs.

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The FDA has revised its Draft Guidance for Industry "Conducting Remote Regulatory Assessments - Questions and Answers", providing answers to frequently asked questions regarding what RRAs are, when and why FDA may use them, and how FDA may conduct them, among others.

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In December 2023, the Questions & Answers (Q&A) documents related to centralised procedures were revised again and published on the European Medicines Agency (EMA) website. The list of Q&As, which can be used by marketing authorisation holders and applicants for centralised procedures, provide answers to any questions that may arise at different stages of the centralised marketing authorisation application.

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We recently reported on a case in which the failure to respond led to a Warning Letter. The U.S. Food and Drug Administration (FDA) has now published another incident that also goes in this direction. The FDA had planned an inspection at a manufacturing facility in Thailand, but all efforts to contact the firm were unsuccessful.

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The FDA recently issued a Warning Letter to a pharmaceutical company in Thailand for violating CGMP regulations and expectations on Quality Oversight.

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At the beginning of 2024, the EMA added 4 new questions and answers to its catalogue of frequently asked questions from the GMP and GDP area.

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The U.S. Food and Drug Administration (FDA) has published two new Warning Letters to companies registered as a manufacturer of over-the-counter (OTC) drug products in the United States. In both cases, the firms did not demonstrate that they adequately tested each shipment of each lot of the incoming components at high-risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination.

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In January 2024, the U.S. FDA issued a Warning Letter to the company "Prime Lab LLC" after having inspected its site in July and August 2023. According to the WL, the firm failed to do proper incoming control tests for identity of their raw materials.

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