483
Moss Tubes Inc.FDA 483 - Moss Tubes Inc. - August 13, 2021
Record Details
An FDA inspection of Moss Tubes Inc., a medical device manufacturer in Castleton On Hudson, NY, revealed two significant issues related to quality system documentation. The firm failed to adequately maintain device history records, specifically lacking traceability for sterility test reports, and did not properly document design validation results in the design history file.
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ID · 946b3ee8-56b0-4d64-82e4-c345e522201f