483
Terumo BCT, Inc.Terumo BCT, Inc. – FDA 483, Jun 26, 2008
Record Details
Gambro BCT, Inc. in Lakewood, CO, a medical device manufacturer, was cited for deficiencies in its complaint handling procedures. The firm failed to adequately investigate complaints involving possible device failures and patient adverse events. Multiple complaints were not fully investigated to determine the root cause, failing to rule out potential performance issues with devices or materials.
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- Denver District Office
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ID · b82ea266-566c-4344-9460-5ea5d9956a27
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