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# 2 Observations on Astellas Pharma FDA-483
- URL: https://www.fdaweb.com/2-observations-on-astellas-pharma-fda-483/
- Published: 2025-12-11T12:00:00.000Z
- Updated: 2026-09-14T15:29:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160367

FDA has released the form FDA-483 issued following a 6/2-6/6 inspection at the Astellas Pharma sterile drug manufacturing facility in Takaoka, Toyama, Japan. The two inspection observations were:

- failure to establish adequate written procedures for production and process controls designed to assure that drug products have the identity, strength, purity, and quality that they are purported or represented to possess; and
- failure of procedures designed to prevent microbiological contamination of drug products purporting to be sterile to include validation of the process.