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# 8 Observations on Jubilant HollisterStier Form FDA-483
- URL: https://www.fdaweb.com/8-observations-on-jubilant-hollisterstier-form-fda-483/
- Published: 2026-10-21T18:37:14.000Z
- Updated: 2026-10-21T18:37:14.000Z
- Author: David McFarland
- Tags: Drugs

FDA has released the Form FDA-483 with eight observations from a 6/8-6/17 inspection at the Jubilant HollisterStier drug manufacturing facility in Spokane, WA. The [inspection observations](https://www.fda.gov/media/195673/download?ref=fdaweb.com) were:

- component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality;
- failure to follow written procedures for the storage of components;
- failure of written records of investigations into unexplained discrepancies to always include the conclusions and follow-up;
- equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its intended use;
- failure to establish the sensitivity of test methods;
- failure of laboratory controls to include the establishment of scientifically sound and appropriate sampling plans designed to assure that components conform to appropriate standards of identity, strength, quality, and purity;
- failure to follow established test procedures; and
- failure to maintain in writing and fully follow the responsibilities and procedures applicable to the quality control unit.