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EBI complaint-handling, record-keeping deficiencies to be resolved within two months, firm says.

This article was originally published in The Gray Sheet

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Executive Summary

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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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