Devices & drugs
Warning letter 726714, Excelvision–Fareva
FDA’s drug office told Excelvision, a Fareva sterile-drug plant in Annonay, France, that finished drugs from that site are adulterated. Investigators found contamination complaints, sterility-test failures, and a plant that could not keep water and mold out of classified rooms. The same kinds of failures had already been cited in an earlier warning letter.
The inspection ran January 12–22, 2026. The products are sterile multi-use drugs that are supposed to stay sterile after the consumer opens them. FDA says that since a November 2024 inspection the firm took a substantial number of complaints of mold, black specks, and discoloration on tips and inner caps. Complaint samples failed sterility testing. Nine such non-sterility events, the letter says, occurred in three years. In one case the organism from a failed complaint sample was Alternaria alternata — the same mold recovered in environmental monitoring of the filling room before and after that batch. The complaint file did not include that match. The firm’s usual root cause was the customer.
Investigators watched operators block unidirectional airflow with their gloves and lean head and torso into an ISO 5 filling zone. Ceilings in classified areas were a material the firm itself called not waterproof and not decontaminable, after repeated water incursions and mold recoveries. Critical product-contact parts were disinfected between batches rather than sterilized.
FDA had recommended a market removal on April 7, 2026. The letter says the firm later issued voluntary recalls for lack of sterility assurance, and that FDA placed the site on Import Alert 66-40 on April 27, 2026. The letter cites a prior warning letter, 320-25-70, for similar CGMP failures: “The recurrence of these violations demonstrates that your firm’s corrective actions were neither effective nor durable.”
fda.gov — Excelvision – Fareva — 726714
These notes paraphrase and quote one public FDA warning letter. They are not legal advice. A warning letter is an administrative notice, not a court judgment. Redaction marks such as (b)(4) are FDA’s.