Actualizaciones regulatorias

FDA issued a Complete Response Letter for HLB’s ribociclib NDA, citing cGMP deficiencies at the Chinese Hengrui manufacturing site.

The FDA has recalled products after CGMP deviations revealed exposure to temperatures outside labeled storage conditions.

The FDA has issued a recall citing CGMP deviations caused by intermittent temperature excursions during storage.

The FDA has initiated a recall of a product because of deviations from current Good Manufacturing Practices (CGMP).

The FDA has issued a recall for products manufactured with a contaminated excipient that was previously recalled by the supplier, citing CGMP deviations.

FDA recalls Next Advanced Antibacterial Hand Sanitizer due to ethanol below label claim and methanol contamination; related products from the same plant also withdrawn.