FDA 483 - J Sterling Industries, LLC - January 08, 2026
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J Sterling Industries, LLC in Kalamazoo, MI, was cited with three observations during an FDA inspection. The firm demonstrated inadequate control over cleanroom environmental conditions, including issues with specifications, monitoring, and excursion investigations. Furthermore, the company's corrective and preventive action (CAPA) procedures were found to be deficient in initiation, risk assessment, root cause analysis, and effectiveness verification. Lastly, equipment maintenance schedules were not adequately established, and equipment installation did not meet manufacturer requirements.
ID · 942d8556-440f-4780-950d-9cdcaa1b0746