During a post-market assurance inspection on June 3, 2024, the Food and Drug Administration issued 18 citations to Phoenix Thera-Lase Systems, LLC, located in Dallas, according to data posted on the FDA’s website.
The FDA website indicates that the citations were delivered to the company as follows:
- ‘The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet the requirements of 801 Subpart B and 21 CFR 830.’
- ‘Written MDR procedures have not been developed.’
- ‘No management representative had been appointed to ensure that quality system requirements are met, and to report to management on the performance of the quality system.’
- ‘Procedures for management review have not been established.’
- ‘Procedures for quality audits have not been established.’
- ‘Procedures for training and identifying training needs have not been adequately established.’
- ‘Procedures for design control have not been established.’
- ‘Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been established.’
- ‘Procedures have not been established to control product that does not conform to specified requirements.’
- ‘Procedures for corrective and preventive action have not been adequately established.’
- ‘Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.’
- ‘The information required by the Global Unique Device Identification Database for each medical device version or model required to bear a unique device identifier (UDI) was not provided.’
- ‘You did not submit a required product report prior to the introduction of the product into commerce.’
- ‘You have not established and maintained records containing a description of quality control procedures with respect to electronic product radiation safety.’
- ‘Failure to furnish to the dealer, at the time of delivery of a product, a certification that the product conforms to all applicable standards.’
- ‘A certification label or tag is not permanently affixed or inscribed and readily accessible to view when the product is fully assembled for use.’
- ‘An identification label or tag is not permanently affixed or inscribed and readily accessible to view when the product is fully assembled for use.’
- ‘Each Class IV laser product does not have affixed a label bearing the DANGER logotype specified in the regulation.’
The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.
According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety and quality.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
