483
Straight Arrow Products, Inc.FDA 483 - Straight Arrow Products, Inc. - October 15, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
Straight Arrow Products, Inc. in Easton, PA, an OTC drug manufacturer, was cited for multiple significant deficiencies during an FDA inspection. The observations highlight severe issues across quality control, process validation, equipment maintenance, stability testing, computer system controls, and annual product reviews. These findings indicate a systemic failure to adhere to Good Manufacturing Practices.
Open in Dashboard
ID · ccaaa68a-8497-4c3b-938e-d6fb94c8d69d