483
International Medication Systems Ltd.International Medication Systems Ltd. – FDA 483, Feb 15, 2023
Record Details
An FDA inspection of International Medication Systems Ltd. in South El Monte, CA, revealed significant deficiencies in data integrity and equipment maintenance. The firm failed to implement appropriate controls over computerized systems, allowing unauthorized data deletion and method editing, and lacked adequate audit trail procedures. Additionally, critical equipment parts were not included in a preventive maintenance schedule.
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ID · c47575fe-f472-41eb-9e94-7cdec3b18d15
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