Custom Assemblies, Inc. Warning Letter Details

Summary

Based on limited metadata, this FDA Warning Letter issued to Custom Assemblies, Inc. on April 6, 2018, concerns medical device manufacturing or assembly operations. Without access to the full letter text or specific subject line, the exact nature of the violations cannot be detailed; however, the warning indicates FDA identified significant compliance concerns with the company's medical device products or manufacturing practices. The letter falls under FDA's medical device regulatory authority, though the specific product category and issuing office details are not available in the provided metadata.