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Based on limited metadata, the FDA issued a Warning Letter to Cooper Institute on December 15, 2021, regarding biologics products. Without access to the full letter text or specific subject line details, the exact nature of the violations cannot be precisely determined from the available information. The warning relates to biologics regulation, though the specific issuing office and violation count are not provided in this metadata summary. To understand the complete regulatory concerns and required corrective actions, the full Warning Letter text would need to be reviewed.