Sunoptic, Jacksonville, FL, Aug. 1 (Maitland, FL).During an inspection of Sunoptic Technologies, Jacksonville, FL, 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. determined that the methods used in or the facilities or controls used for the manufacture, packing, storage or installation of the firm's products, Dental Probes and light sources are not in conformity with the GMP GMP (guanosine monophosphate): see guanine. requirements of the Quality Systems (QS) regulation. The firm failed to validate with a high degree of assurance, and approve according to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. established procedures, the results of process that cannot be fully verified by subsequent inspection and test, and failure to documents the validation activities and results, the Aug. 1 warning letter stated. For example, the firm "did not perform a validation of the cleaning and sterilization sterilization Any surgical procedure intended to end fertility permanently (see contraception). Such operations remove or interrupt the anatomical pathways through which the cells involved in fertilization travel (see reproductive system). processes for its light source devices to determine if the process parameters are appropriate." Also, Sunoptic did not perform a validation of the manufacturing process after the equipment critical to the process was moved from its original location, FDA wrote. The inspection revealed the company failed to implement procedures to ensure the device history records (DHRs) for each unit are maintained to demonstrate that the device is manufactured in accordance with DMR (Digital Media Receiver) See digital media hub. and QS regulation. Specifically no primary ID label and labeling used for each production unit of the Dental Probe was not included as part of your DHR DHR De Heer (Dutch: Mister) DHR Department of Human Resources DHR Department of Historic Resources (Virginia) DHR Dihydrorhodamine DHR Device History Record DHR Director of Human Resources procedure. The company also failed to document acceptance activities including the acceptance activities performed, the date performed, the results, the signature of the individual conducting the acceptance activities, and, where appropriate, the equipment used. Additionally, the firm failed to implement procedures for quality audits and conduct such audits to assure that the quality system is in compliance with QS regulation. The inspection also revealed that the Dental Probes did not have an approved application for pre-market approval and the Dental Probes are misbranded mis·brand tr.v. mis·brand·ed, mis·brand·ing, mis·brands To brand or label misleadingly or fraudulently. Adj. 1. because FDA was not notified of the firm's intent to introduce the devices into commercial distribution as required, the letter added. Lab; QS/QC; Doc. 14213W |
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