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# UBI FDA-483 Has 5 Observations
- URL: https://www.fdaweb.com/ubi-fda-483-has-5-observations/
- Published: 2025-12-18T12:00:00.000Z
- Updated: 2026-09-14T15:29:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160411

FDA has released the form FDA-483 issued following a 10/6-10/14 inspection at the UBI Pharma drug manufacturing facility in Hsinchu, Taiwan. The five inspection observations were:

- 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 processes to monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product;
- failure to establish and/or follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- failure to maintain and/or fully follow written responsibilities and procedures applicable to the quality control unit; and
- 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.