Devices

QS Problems Found at Tosoh Bioscience

An FDA inspection at Tosoh Bioscience, Grove City, OH, on various dates between 5/16 and 6/28 found Quality System Regulation violations in the firm’s work as the initial importer, complaint handling unit, and repacker/relabeler of high performance liquid chromatographs used in measuring hemoglobin, automated immunoassay analyzers used in treating disease, and laboratory solutions, assays, and test-cup reagents. The company also manufactures a hemolysis and wash solution used with the chromatographs, according to an 8/5 Warning Letter from the agency’s Cincinnati District Office. Specific violations listed on an FDA-483 included:

failing to review, evaluate, and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications;
failing to establish and maintain adequate procedures for implementing corrective and preventive action, including requirements for analyzing processes, work operations, concessions, audit reports, quality reports, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming products or other quality problems;
failing to verify and validate corrective and preventive actions to ensure that such actions are effective and do not adversely affect the finished device;
failing to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
failing to establish and maintain schedules for adjusting, cleaning, and otherwise maintaining equipment to ensure that manufacturing specifications are met; and
failing to establish and maintain procedures for quality audits and to conduct such audits to assure that the quality system complies with the established quality system requirements and to determine quality system effectiveness.

The company’s responses were inadequate or their adequacy could not be assessed. FDA asks that the company submit according to an agency schedule certification by an expert outside consultant that he or she has conducted an audit of the company’s manufacturing and quality assurance systems relative to regulatory requirements.

Tosoh was told to take steps to correct the violations and prevent their recurrence and to respond with a list of specific actions taken, documentation of the corrective actions, and a timetable for completion.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome