483
Alfa Scientific Designs IncFDA 483 - Alfa Scientific Designs Inc - June 20, 2013
Record Details
An FDA inspection of Alfa Scientific Designs Inc. in Poway, CA, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to establish and maintain adequate procedures for monitoring and controlling validated process parameters, managing storage areas, and ensuring routine equipment calibration and maintenance. These observations indicate a need for improved procedural controls within the manufacturing operations.
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ID · 87ee3450-bd0f-4ccd-925b-da91c62bb5b0