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483
•Medwaves Inc•September 11, 2023

FDA 483 - Medwaves Inc - September 11, 2023

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Record Details

Medwaves Inc, a medical device manufacturer in San Diego, CA, was cited with two observations during an FDA inspection. The inspection revealed deficiencies in the firm's quality system, specifically regarding inadequate employee training procedures and a lack of established process controls for product storage. These issues indicate a need for improved adherence to regulatory requirements.

Company
Medwaves Inc
Inspection Date
September 11, 2023
Product Type
Device
Office
Division of Pharmaceutical Quality Operations IV
Person
  • Jenny L. Chisem
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ID · df38303e-43fb-436e-8945-fe4de9a782a1

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