PT. TEAM-METAL INDONESIAAugust 8, 2018

FDA 483 - PT. TEAM-METAL INDONESIA - August 08, 2018

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Record Details

An FDA inspection of PT. TEAM-METAL INDONESIA, a medical device manufacturer in Batam, Indonesia, revealed a significant issue with process validation. The firm failed to adequately validate machining processes for critical medical device components, relying on sampling rather than full verification. This indicates a serious lapse in quality system procedures related to ensuring product quality and safety.

Company: PT. TEAM-METAL INDONESIA
Inspection Date: August 8, 2018
Product Type: Device
Office: Office of Inspections and Investigations
Person: James R. Montero

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ID · 41d2f541-08a1-4dc6-9700-f9bbe21074b7