Drugs

Repeat CGMP Violations Seen in Excelvision Inspection

David McFarland

— 2 min read
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A 1/12-1/22 FDA inspection at the Excelvision – Fareva drug manufacturing facility in Annonay, France, found repeat significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/25 Warning Letter says the specific violations were:

  • failure to thoroughly investigate any unexpected discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
  • 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 maintain floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable in aseptic processing areas and establish an adequate system for maintaining equipment used to control the aseptic conditions; and
  • failure to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

FDA acknowledges the firm’s commitment to cease production of drugs on specified lines and suspend production of drug products on other specified lines for the U.S. market until they have been replaced. It says the company issued a recall of all redacted drug products currently in distribution from the U.S. market due to lack of sterility assurance.

The letter notes that a previous Warning Letter cited similar severe CGMP violations, demonstrating that the firm’s corrective actions were neither effective nor durable. “Your failure to correct these issues led to unacceptable drug products being distributed to the U.S. market,” FDA says.

Significant findings in the letter demonstrate that Excelvision does not operate an effective quality system in accord with CGMP, FDA says. In addition to the lack of management oversight of the firm’s production operations, it says, it found the firm’s quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. “Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements,” FDA says.

The agency recommends that Excelvision retain a qualified consultant to evaluate its operations through a comprehensive six-system audit of its entire operations and assist it in meeting CGMP requirements.

FDA placed all of the firm’s drugs and drug products offered for import into the U.S. on a 4/27/2025 Import Alert.

Excelvision was told to correct the violations promptly 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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