FDA WARNING_LETTER - Panoramic Rental Corp. - April 24, 2015
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On October 1, 2015, the FDA issued a Warning Letter to Young Innovations, Inc., regarding its Panoramic Corporation facility in Fort Wayne, Indiana, following an inspection from April 15-24, 2015. The inspection found that the firm's Panoramic PC-1000 and PC-1000/Laser 1000 dental x-ray products are misbranded devices under the Federal Food, Drug, and Cosmetic Act.
Significant violations include the failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures as required by 21 CFR 803.17. Specifically, Procedure No. 7230, "Customer Communication," lacked definitions for reportable events, a standardized review process for determining reportability (including investigation instructions), and provisions for timely transmission of complete MDRs, such as supplemental report requirements and submission of all known information. The firm's May 5, 2015, response was deemed inadequate as revised SOPs were not provided for evaluation, and evidence of initial MDR filings was missing.
Additionally, the firm failed to report a correction or removal for the PC-1000's rotating arm/chassis collapsing issue, as required by 21 CFR 806.10. Despite two customer alerts (February 7, 2003, and February 19, 2
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