483
ARP Manufacturing, LLCARP Manufacturing, LLC – FDA 483, Aug 29, 2019
Record Details
ATE Manufacturing, LLC, a medical device manufacturer in Centennial, CO, received two observations during an FDA inspection. The firm was cited for inadequate procedures regarding supplier assessment and approval, specifically concerning ongoing supplier evaluations. Additionally, the inspection found deficiencies in the control of nonconforming material, including incomplete disposition records.
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ID · edad7585-f04a-4e95-8bb2-f47f0cdde6be
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