FDA 483 - Straight Arrow Products, Inc. - November 22, 2019

An FDA inspection of Straight Arrow Products, Inc. in Bethlehem, PA, a human and vet drug manufacturer, revealed significant deficiencies in their quality systems. Observations included inadequate complaint handling, lack of expiration dates for animal drug products, insufficient production and process controls, and a missing stability program. Additionally, the firm failed to ensure proper laboratory record review, maintain adequate computer system controls for data integrity, and appropriately design and validate its water system, with one observation being a repeat finding.