483
Flextronics Electronics Technology (Suzhou) Co., Ltd.Flextronics Electronics Technology (Suzhou) Co., Ltd. – FDA 483, Nov 5, 2018
Record Details
Flextronics Electronics Technology (Suzhou) Co., Ltd., a foreign medical device contract manufacturer, was inspected by the FDA from November 5-8, 2018. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding corrective and preventive actions and the control of nonconforming products. These issues indicate a lack of adequately established and implemented procedures for ensuring product quality and preventing recurrence of problems.
- Inspection date
- November 5, 2018
- Product type
- device
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ID · 6bdbd56b-a52b-4db9-914d-e750ecf080a2
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