FDA 483 - Packaging Unlimited LLC - February 21, 2020

An FDA inspection of Stroughhaven, Inc. d.b.a Packaging Unlimited, a contract drug labeler/packager in Louisville, KY, revealed significant deficiencies. The firm failed to maintain complete batch production and control records, ensure proper identification of processing lines, and exercise strict control over drug product labeling. These issues indicate a lack of adequate controls in their packaging and labeling operations.