483
Hitachi High-Technologies Corp., Omuta CenterHitachi High-Technologies Corp., Omuta Center – FDA 483, Feb 28, 2019
Record Details
During an inspection of Hitachi High-Technologies Corp.'s Omuta Center in Japan, the FDA observed two significant issues. The firm failed to maintain the acceptance status of products and lacked adequate procedures to prevent contamination in its manufacturing clean room. These conditions indicate deficiencies in quality control and environmental monitoring.
- Inspection date
- February 28, 2019
- Product type
- device
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ID · 0e1e9f73-f611-4769-a6f4-643409fe6dcb
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