Drugs

Rechon Life Sciences Violations

An 8/26-9/6/2024 FDA inspection at the Rechon Life Sciences drug manufacturing facility in Skane Lan, Sweden, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/30 Warning Letter says the specific violations were:

failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch was already distributed;
failure to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions; and
failure to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair.

The letter says the firm’s responses to the inspection observations were inadequate. Rechon was told to promptly correct the violations and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome