483
Pharmichem Testing Services IncFDA 483 - Pharmichem Testing Services Inc - April 03, 2019
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Record Details
Phanichem Testing Services Inc, a contract testing laboratory in Tinley Park, IL, received a Form 483 for failing to thoroughly review unexplained discrepancies and out-of-specification results. The firm's investigations into missing or OOS temperature readings from monitoring equipment were inadequate, and corrective actions for recurring equipment malfunctions were not effective. This indicates significant issues with quality control and data integrity practices.
- Office
- Chicago District Office
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