EBI complaint-handling, record-keeping deficiencies to be resolved within two months, firm says.
This article was originally published in The Gray Sheet
EBI DYNA-FIX COMPLAINT HANDLING, RECORD-KEEPING DEFICIENCIES should be resolved within a month or two, Parsippany, New Jersey-based Electro-Biology Inc. says. The company has been working with FDA to resolve problems cited in an Aug. 28 warning letter issued following a July 30-Aug. 14 inspection of its Parsippany facility, where the firm manufactures its Dyna-Fix standard and wrist fixator systems.
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