MEDICAL DEVICES: 6840WPowertron Medical Devices, Jacksonville, FL, Aug. 7 (Florida). The specification developer and distributor of medical product replacement batteries was cited for QS deviations, including complaint-handling problems and a lack of quality audit procedures. Misbranding resulted from a failure to submit 510(k)s and a lack of MDR MDR, n See multidrug resistance. MDR, n the abbreviation for minimum daily requirement, specifically the Minimum Daily Requirements for Specific Nutrients compiled by the United States Food and Drug Administration. procedures. The firm was advised of the need for the words Amanufactured by@ or Adistributed by@ on its labeling. 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. asked Powertron to submit certification of an audit by an outside consultant. Premarket submissions will not be cleared and export certificates will not be approved until the violations are corrected. A related warning letter was issued to Sunn sunn n. 1. A tropical Asian plant (Crotalaria juncea) having clusters of yellow flowers. 2. A tough fiber obtained from the stems of this plant, used for cordage. Battery (Doc. 6844W, page 9). An earlier warning letter, dated Feb. 14, 1996 (Doc. 3787W), also listed GMP GMP (guanosine monophosphate): see guanine. lapses. The company was audited May 4-6 and 12-13. |
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