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483
•All Quality & Services, Inc.•April 10, 2026

FDA 483 - All Quality & Services, Inc. - April 10, 2026

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Record Details

All Quality & Services, Inc., a contract manufacturer in Fremont, CA, was cited for significant deficiencies in its quality system during an FDA inspection. The firm lacked adequately documented procedures for controlling nonconforming products, corrective actions, and personnel training. Additionally, the inspection found issues with management review records and the absence of written medical device reporting procedures.

Company
All Quality & Services, Inc.
Inspection Date
April 10, 2026
Product Type
Device
Office
Division of Human and Animal Food Operations - West V
People
  • Brittany D. Mccracken
  • Sasha L. Eckstein
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ID · d44685ff-9fc6-4670-a303-90066356893f

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