483
Advanced Laboratories, Inc.Advanced Laboratories, Inc. – FDA 483, Feb 11, 2016
Record Details
An FDA inspection of Advanced Laboratories, Inc. in Clayton, NC, a contract laboratory, revealed two significant observations. The firm was cited for deficiently written or followed procedures for instrument calibration, specifically regarding balance accuracy and certified ranges. Additionally, the inspection found inadequate laboratory controls, lacking scientifically sound specifications and action limits for media monitoring, which could impact drug product quality.
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ID · ec135662-c2fa-4c77-a242-2bccdf743175
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