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A recent FDA Warning Letter to a Chinese OTC manufacturer highlights serious deficiencies in analytical testing, inadequate quality oversight, and multiple data integrity issues. These include missing data, discrepancies between original and re-written testing records and certificates of analysis (COAs), and the use of correction fluid (white-out) to alter laboratory documentation.

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A Chinese manufacturer of OTC products (such as alcohol swabs) received a warning letter from the FDA due to serious violations. The warning letter is not based on an on-site inspection, but on a review of documents that the pharmaceutical manufacturer submitted to the FDA upon request. The deficiencies include the areas of quality control and quality assurance, process validation and the water system. Read more.

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The U.S. Food and Drug Administration (FDA) has issued a new Warning Letter due to CGMP violations related to combination products. Key violations include inadequate controls to ensure the sterility of drug products, deficient dissolution testing, and a lack of process validation.

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The United States Food and Drug Administration has issued a Warning Letter to a Chinese manufacturer. The violations include inadequate raw material testing and insufficient stability testing programs.

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With the draft chapter <1110>, the USP completes its programme with recommendations on the subject of contamination control strategy, as already called for in other documents.

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A manufacturer of OTC products from Mesquite, Texas received a Warning Letter from the US FDA for deficiencies in various areas ranging from microbiology and raw material analysis to cleaning and disinfection.

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The US FDA recently published a further Warning Letter to a Chinese manufacturer, which has joined the growing list of companies that have established no or inadequate quality control units due to the lack of testing and control of raw materials used.

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In a recent GMP news, we pointed out deficiencies, especially regarding stability data, of an Indian manufacturer by referencing an FDA Warning Letter. This Warning Letter also offers interesting interpretation aids on the subject of cleaning validation. What is the FDA interested in?

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The International Coalition of Medicines Regulatory Authorities (ICMRA) launched the "Collaborative Hybrid Inspection Pilot (CHIP)" in 2021. Now a report has been published summarising key findings and proposing next steps.

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After inadequate Root Cause Analyses were repeatedly the subject of FDA Warning Letters, a 'Statement of Non-Compliance with GMP' has now also been published in EudraGMDP. And another Warning Letter.

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