Excelvision - Fareva — FDA Warning Letter, June 25, 2026: CGMP/Finished Pharmaceuticals/Adulterated

FDA Warning Letter — Violations FDA cited at Excelvision - Fareva

WARNING LETTER Excelvision - Fareva MARCS-CMS 726714 — June 25, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Return Receipt Requested Product: Drugs Recipient: Recipient Name Mr. Bernard Fraisse Recipient Title CEO Excelvision - Fareva 1041 Chemin de la Digue du Rhône 07300 Tournon-sur-Rhône France BFraisse@fareva.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-98 June 25, 2026 Dear Mr. Fraisse: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Excelvision, FEI 3007058211, at 27 Rue de la Lombardiere, Annonay, from January 12 to 22, 2026. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). We reviewed your February 12, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. During our inspection, our investigators observed specific violations including, but not limited to, the following. 1. Your firm failed 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 has already been distributed (21 CFR 211.192). You failed to adequately investigate customer complaints for the various sterile (b)(4) drug products (prescription and over-the-counter) you manufacture. Your investigations were not thorough, did not appropriately expand in scope, and lacked a scientifically supported determination of root causes. You also failed to identify and implement adequate and timely corrective actions and preventive actions (CAPAs). Your product is intended to maintain sterility of its contents after (b)(4) by the consumer. However, since our previous inspection in November 2024, your firm has received a substantial number of complaints related to the presence of contamination. Visible evidence of contamination included mold, black specks, and discoloration on the tips and inner caps of containers for your (b)(4) drug product, (b)(4) . Several complaint samples subsequently failed sterility testing. Notably, nine such non-sterility events have occurred in the last three years. You failed to adequately determine which hazards in your manufacturing operation and container-closure systems led to these critical, repeated incidents of contamination in your (b)(4) drug products. Specifically, you failed to adequately investigate potential container-closure integrity defects that would allow ingress of microbial contamination, which your product is intended to strictly preclude. You also failed to adequately assess potential sources of contamination from the manufacturing process as you neglected to evaluate relevant environmental and personnel monitoring (EM/PM) data. For example, the microorganism recovered from the failed complaint sample sterility test involving (b)(4) batch (b)(4) was identified as Alternaria alternata . This was the same microorganism recovered in EM/PM samples collected both before and after this batch was manufactured, including in the room where this batch was filled. Your complaint investigation report did not include this critical information. Similarly, your firm also failed to adequately investigate numerous contamination complaints related to your (b)(4) products. Instead of conducting a thorough, scientifically supported, and evidence-based root cause analysis, your firm attributed most of the root causes to inadequate handling by customers who used your pro