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# 13 Observations in Zhejiang Hushai Inspection
- URL: https://www.fdaweb.com/13-observations-in-zhejiang-hushai-inspection/
- Published: 2026-07-16T12:00:00.000Z
- Updated: 2026-09-14T13:43:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161466

FDA has released the form FDA-483 with 13 observations from a 4/13-4/24 inspection at the Zhejiang Hushai Pharmaceutical Co. drug manufacturing facility in Zhejiang, China. The inspection observations were:

- failure to make written records of investigations into unexplained discrepancies or the failure of a batch or any of its components to meet specifications;
- failure to establish and follow written procedures to prevent microbiological contamination of drug products purporting to be sterile, including adequate validation of the sterilization process;
- aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions;
- failure of laboratory records to include complete data derived from all tests, examinations, and assays necessary to assure compliance with established specifications and standards;
- failure of laboratory controls to include the establishment of scientifically sound and appropriate test procedures designed to assure that components, in-process materials, and drug products conform to appropriate standards of identity, strength, quality, and purity;
- failure to establish control procedures which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process materials and the drug product;
- In-process specifications for sampling and testing of in-process materials and drug products were not derived from previous acceptable process average and process variability estimates and were not determined by the application of suitable statistical procedures;
- failure to maintain equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product;
- failure of written records of investigation of a drug complaint to include the follow-up;
- backup data is not assured as exact, complete, and secure from alteration, erasure, or loss through keeping hard copy or alternate systems;
- failure to provide equipment for adequate control over air pressure, microorganisms, dust, humidity, and temperature when appropriate for the manufacture, processing, packing, or holding of a drug product; and
- failure to fully follow the responsibilities and procedures applicable to the quality control unit.