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Stability testing of drug products is required by 21 CFR 211.166 of the cGMP guidelines. There has been an increase in GMP violations related to stability testing. A few days ago, a German company received an FDA Warning Letter in which, among others, the stability program was criticized.

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The US Food & Drug Administration (FDA) recently sent a Warning Letter to a US pharmaceutical company criticising batch record design and review and quality oversight.

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The first FDA warning letter of the year goes to a Chinese contract manufacturer of over-the-counter (OTC) drug products for multiple violations of current good manufacturing practice (cGMP).

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Four of five Warning Letters recently published broached the issue of handling deviations and inadequate CAPA.

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EMA and its European and international partners are launching a pilot programme to increase their cooperation in the inspection of manufacturers of sterile medicines for human use.

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The U.S. Food and Drug Administration (FDA) has issued a warning letter to Henan Kangdi Medical Devices Co. Ltd. due to, among others, the failure to establish an adequate stability program. Furthermore, the quality unit was not provided with the appropriate authority and sufficient resources to carry out its responsibilities.

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Report indicates persistent challenges and concerns with FDA foreign inspections.

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The U.S. Food and Drug Administration (FDA) recently warned Teligent Pharma, Inc., for different significant violations of current good manufacturing practice (CGMP) at the company's facility in Buena, New Jersey. The FDA cites the company, among others, for failing to thoroughly investigate out-of-specification (OOS) test results.

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The U.S. Food and Drug Administration (FDA) has issued a warning letter to Wild Child WA Pty Ltd., that summaries three significant GMP issues identified during a 5-day inspection of the company's manufacturing facility in Malaga, Western Australia. The core issue is the non-compliance with requirements specified in the United States Pharmacopeia (USP).

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From inadequate cleaning to poor laboratory controls of quality and purity - a manufacturer of homeopathics in the U.S. received a Warning Letter from the FDA.

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