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FDAnews Device Daily Bulletin
Empty Syringes Lead to Warning Letter
June 11, 2009
Inadequate corrective and preventive action procedures prevented Amsino USA from detecting nonconforming manufacturing processes that led to the production of several air-filled syringes, according to an FDA warning letter
. The FDA cited the company, which manufactures sodium chloride and heparin catheter lock-flush solutions, for not investigating the possible root causes of the empty syringes. The company discarded the syringes, but it did not have an acceptance limit for the type or number of discards, the letter says.
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