Incoming inspection records were reviewed for the swab provided in the id now strep a 2 kit, which is manufactured by (b)(4).Inspection is designed to test the durability of the swab under normal use conditions in a health care facility.All inspection specifications for the sterile foam swab pn 25-1506 1pf, lot number # 5802 were met.The current incident rate for damaged/breaking swabs for lot 5802 based on the total lot count is (b)(4).(b)(4) (manufacturer) reported that they inspected their retention samples, and all were found as expected with no visible or detectable flaw in the applicator stick that could cause premature breakage.The batch record was reviewed and all quality checks performed passed inspection.There were no non-conformance raised during the manufacture of lot # 5802.
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