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# Rechon Life Sciences Violations
- URL: https://www.fdaweb.com/rechon-life-sciences-violations/
- Published: 2025-06-03T12:00:00.000Z
- Updated: 2026-09-14T15:13:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159289

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](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rechon-life-science-ab-701040-04302025?ref=fdaweb.com) 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.