SANMINA SCI Systems Malaysia Sdn. Bhd. – FDA Inspection, Oct 20, 2016

Record Details

This FDA Inspection record concerns SANMINA SCI Systems Malaysia Sdn. Bhd., with an inspection on October 20, 2016, issued by the Office of Inspections and Investigations, covering biologics.

Company: SANMINA SCI Systems Malaysia Sdn. Bhd.
Inspection Date: October 20, 2016
Product Type: Biologics
Office: Office of Inspections and Investigations
Person: Catherine J. Laufmann (Investigator)

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ID · b23c0d75-31b7-4384-af22-4d5db53514a8

Inspection Facts

Inspection number: 992712
FDA center: Biologics
Project area: Blood and Blood Products
Outcome: Form 483 issued

FDA Citations

21 CFR 820.100(b)Documentation
21 CFR 820.198(e)Records of complaint investigation
21 CFR 820.75(a)Lack of or inadequate process validation

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FDA Inspection

SANMINA SCI Systems Malaysia Sdn. Bhd.October 20, 2016