Acacia Engineered Products.Franklin, TN, March 20 (New Orleans) The IsoBalance medical device that Acacia Engineered Products manufactures was declared both adulterated a·dul·ter·ate tr.v. a·dul·ter·at·ed, a·dul·ter·at·ing, a·dul·ter·ates To make impure by adding extraneous, improper, or inferior ingredients. adj. 1. Spurious; adulterated. 2. Adulterous. and misbranded mis·brand tr.v. mis·brand·ed, mis·brand·ing, mis·brands To brand or label misleadingly or fraudulently. Adj. 1. by FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. due to several violations. FDA wrote that the company does not have an approved application for premarket approval (PMA) or for an investigational device exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE.) The device is also misbranded because the company did not notify FDA of its intent to introduce the device into commercial distribution. The IsoBalance is misbranded because the device was manufactured, prepared, propagated, compounded or processed in an establishment not duly registered and the device was not included in a list as required. FDA's inspection revealed that device is adulterated because of violations of GMP requirements of the Quality System (QS) regulation. The firm had failed to establish or implement the QS procedures required, FDA wrote. PMA; QC/QS |
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