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The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good manufacturing practice (CGMP) requirements, and one firm that has failed to submit an approved application for premarket approval (PMA).

The US Food and Drug Administration (FDA) has issued several recent warning letters to companies, including for failing to comply with current good manufacturing practices (CGMP), marketing unauthorized products, and failing to obtain proper informed consent from trial participants.

The US Food and Drug Administration (FDA) recently warned two drugmakers, Phoenix-based Vasco Rx and Commerce, CA-based Samson Pharmaceuticals, for good manufacturing practice violations at their facilities.

A US Food and Drug Administration (FDA) inspection at a Canada-based over-the-counter (OTC) drug manufacturing facility revealed violations of good manufacturing practices (GMP)—similar to those cited in 2012 and 2014.

The US Food and Drug Administration (FDA) recently sent warning letters to three companies concerning facilities in India and one in Germany for current good manufacturing practices (GMPs) and nonclinical study-related violations.

The US Food and Drug Administration (FDA) has warned UK-government owned Porton Biopharma Limited for repeat good manufacturing practice (GMP) violations at its Salisbury, UK facility.

The US Food and Drug Administration (FDA) sent warning letters to an active pharmaceutical ingredient (API) supplier and a pharmaceutical company in India for violating current good manufacturing practices (cGMPs), which included issues related to data integrity.

The US Food and Drug Administration (FDA) has warned an oncology drug company for repeatedly overstating the efficacy of its drug in advertisements while failing to adequately disclose the associated risks. The agency also issued several warning letters to companies for violations of current good manufacturing practices (CGMP) and for marketing products for non-approved indications.

The US Food and Drug Administration (FDA) recently posted four warning letters to pharmaceutical manufacturers in the US, Canada, and China for violations of current good manufacturing practices (CGMPs) and for marketing unapproved drug products.