Ambco Electronics, Tustin, CA, Jan. 6 (Los Angeles). During an inspection of the medical device firm, conducted Oct. 4-10, an FDA investigator determined the manufacturer of automatic, semi-automatic and manual audiometers had failed to establish, maintain and control a device-specific quality system. No quality plan defining the quality practices, resources and activities relevant to the devices that were designed and manufactured was established or implemented; no management representative was appointed to ensure that quality system requirements were effectively established and maintained; no procedures for conducting management reviews were available; and the company had failed to establish and implement procedures for conducting quality audits. Additionally, neither Medical Device Reporting procedures nor procedures for implementing a CAPA plan were established. The manufacturer was also hit with failure to establish and implement procedures for receiving, reviewing and evaluating complaints by a formally designated unit. Lastly, Ambco was not processing validation activities, and did not have methods established for addressing the identification, documentation, evaluation, segregation, disposition and investigation of nonconforming product. CAPA, C-H, MDR, QC/QS, Val.
Lordex, Houston, Dec. 29 (Dallas). FDA inspected the company’s plants in Houston and Brookshire, TX, Oct. 15 through Nov.15, and discovered that the manufacturer’s products–the RX-1 Lumbar Extension Machine and the Lordex Decompression Unit, which are physical medicine devices intended for treating patients with lower back pain–were in violation of GMP/Quality System requirements for medical devices. Significant GMP inspectional observations at both plants included failure of management with executive responsibility to ensure that an adequate and effective quality system was fully implemented and maintained at all levels of the organization; failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conformed to specified requirements, including quality requirements; and failure to establish and maintain procedures for acceptance of incoming product. Further, the warning letter pointed out the manufacturer had failed to establish and maintain process control procedures to include documented instructions, standard operating procedures (SOPs), and methods to define and control the manner of production; and failed to establish and maintain procedures to control product that does not conform to specified requirements, including the identification, documentation, segregation, disposition and investigation of nonconforming product. Additionally, it was noted the company had not established procedure to determine that the devices were manufactured in accordance with a device master record. The firm also had no device history records in order to document device assembly acceptance results, device labeling and serial numbers and dates of manufacture; and it had not established procedures and documentation to include design plans, design inputs, design outputs, design reviews, design verification and validation, design risk analysis, design transfer, design changes and design history files. Lastly, Lordex was hit with failure to establish and maintain procedures for receiving, reviewing and evaluating complaints by a formally designated unit. C-H, Design, QC/QS, Val
Odyssey Medical, Memphis, TN, Dec. 4 (New Orleans). Following an Oct. 20-24 inspection, FDA determined the manufacturer of Punctal Occluders to be in violation of Quality System Regulation for medical devices. Specifically, the inspection revealed an inadequate quality control system, inadequate quality audits, inadequate training of firm personnel, inadequate process validation, and incomplete receiving and inspection reports. Furthermore, the agency cited Odyssey for incomplete and inadequate CAPA action procedures, inadequate device master records, and inadequate complaint procedures. No details as to what deemed the company’s quality system approaches inadequate were provided in the warning letter. CAPA, C-H, QC/QS, Val
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