CGR Products MN, LLC.March 12, 2026

FDA 483 - CGR Products MN, LLC. - March 12, 2026

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Record Details

An FDA inspection of CGR Products MN, LLC, a manufacturer of sterile seal devices in Inver Grove Heights, MN, revealed significant deficiencies in their quality system. The firm failed to adequately document production controls, including process parameters and adjustments for lamination and slitting processes. Additionally, records for nonconforming products and the effectiveness of corrective actions were not properly maintained.

Company: CGR Products MN, LLC.
Inspection Date: March 12, 2026
Product Type: Other
Office: Minneapolis District Office
Person: Albert L. Nguyen

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