483
Mak Healthcare IncFDA 483 - Mak Healthcare Inc - February 26, 2019
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An FDA inspection of Mak Healthcare Inc in Schaumburg, IL, an initial importer and device refurbisher, revealed a significant lack of established quality system procedures. The firm failed to implement formal processes for complaint handling, purchasing controls, and a general quality policy. This indicates fundamental deficiencies in their quality management system.
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ID · 85d7a369-c232-4af5-9778-318d966e98d9