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•Stoll Metalcraft Inc•October 11, 2023

FDA 483 - Stoll Metalcraft Inc - October 11, 2023

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Record Details

Stoll Metalcraft Inc, a Class II medical device contract manufacturer in Valencia, CA, was inspected by the FDA. The inspection revealed two significant observations related to quality system deficiencies. These included inadequate documentation of out-of-calibration equipment evaluations and incomplete device history records.

Company
Stoll Metalcraft Inc
Inspection Date
October 11, 2023
Product Type
Device
Office
Division of Pharmaceutical Quality Operations IV
Person
  • Kelvin Cheung
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ID · 9933fd59-098e-4ff3-a2e1-91db972cdc26

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