483
Pt Ciba Vision BatamPt Ciba Vision Batam – FDA 483, Aug 26, 2022
Record Details
An FDA inspection of Pt. Ciba Vision Batam in Batam Island, Indonesia, revealed significant compliance issues. The firm failed to submit required Medical Device Reports for device malfunctions and did not adequately validate processes. Additionally, procedures for corrective and preventive actions were found to be deficient.
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ID · 80942555-fd34-4a62-9439-9b81321a68ed
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