Plastic surgery device maker draws FDA warning letter

(c) To avoid duplicative listings, a general and plastic surgery device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed in one subpart only. (d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.

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Whitehall Manufacturing received a warning letter for multiple violations concerning its whirlpool immersion hydrotherapy and dry heat therapy devices. Whitehall, a division of Acorn Engineering Company located in the City of Industry, Calif., produces healthcare and rehabilitation equipment, including physical therapy and sports medicine products.

Mantienen descuento en multas y amnista en Laredo Laredo, Texas.- La juez Rossie Cuellar de la Corte Municipal de Laredo anunci que el tercer programa de de amnista contina en curso, permitiendo a los ciudadanos limpiar su record de violaciones de trfico y ordenes de detencin pendientes. Este programa de amnista inici el pasado 16 de febrero y concluir el prximo 4 de marzo.

Light Age, a New Jersey-based manufacturer of class II medical lasers, drew an FDA warning letter for 12 different violations flagged during a fall 2017 site inspection. The warning came after the FDA was not satisfied with the firm’s December 2017 response to nonconformities listed in a Form 483.

A maker of medical equipment, health-care supplies, and radiation products used for general and plastic surgery was cited for quality systems violations in the only device-related warning letter released by the US FDA this week.

[FR Doc. 2016-04496 Filed 3-2-16; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 [Docket No. FDA-2016-N-0400] General and Plastic surgery devices; reclassification of Blood Lancets AGENCY: This proposal would be subject to an environmental analysis in.

Breast-Implant Maker Gets ‘Approvable Letter’ From FDA. Mentor must still meet requirements to bring back controversial devices. Please note: This article was published more than one year ago. The facts and conclusions presented may have since changed and may no longer be accurate. And "More information" links may no longer work.

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First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize a lack of effective document control system compliance. Two recent warning letters are patent examples. Both highlight the vital importance of documenting evidence and risk management activities to maintain compliance with FDA guidelines.

Last month, the FDA announced it was taking. leading the drug maker to issue a series of revised and more stringent warnings about Propulsid in a form commonly known as "Dear Doctor" letters. Under.

FDA 483 – FDA Warning letter FDA inspect medical device companies against the GMP ( 21 CFR 820 ) requirements, if the firm is not complying with GMP at the time of inspection, FDA will issue form 483 with non-conformities observed during the inspection.

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