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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.

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.

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.

In September, a US pharmaceutical manufacturer received a Warning Letter from the FDA due to GMP violations in the areas of equipment cleaning, drug stability and handling complaints.