483
CGR Products MN, LLC.CGR Products MN, LLC. – FDA 483, Mar 12, 2026
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.
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