483
PureTek CorporationFDA 483 - PureTek Corporation - March 07, 2025
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PureTek Corporation, a drug manufacturer in San Fernando, CA, received a Form 483 with two observations. The inspection revealed deficiencies in documenting on-the-job training for employees performing GMP operations and a failure to limit access to the storage area for labels and labeling materials to authorized personnel. These findings indicate issues with personnel qualification and material control.
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ID · 9d4c89d7-2ea2-4e56-accd-6b608d97051a