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Talk to a SpecialistTalk to a SpecialistBased on limited metadata, Spectrum Medical Ltd, a medical device manufacturer, received an FDA Warning Letter on September 29, 2023. Without access to the full letter text or subject line, the specific nature of the violations cannot be determined from the available information. The warning relates to FDA device regulation, though the specific issuing office is not identified in the metadata provided. To understand the particular compliance issues cited, the complete Warning Letter would need to be reviewed.