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# Alvotech EF FDA-483 Released
- URL: https://www.fdaweb.com/alvotech-ef-fda-483-released/
- Published: 2026-07-16T12:00:00.000Z
- Updated: 2026-09-14T13:43:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161465

FDA has released the form FDA-483 issued following a 4/29-5/8 inspection at Alvotech EF, a biological drug substance/product manufacturer in Reykjavik, Iceland. The specific inspection observations were:

- procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed;
- failure of procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including adequate validation of the aseptic process;
- failure of laboratory controls to include the establishment of scientifically sound and appropriate test procedures designed to assure drug products conform to appropriate standards of identity, strength, quality, and purity;
- failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed; and
- failure to fully follow the responsibilities and procedures applicable to the quality unit.