FDA 483 - American Spraytech LLC - January 24, 2025

American Spraytech LLC, a drug manufacturer in Branchburg, NJ, received a Form 483 with three observations. The inspection revealed significant deficiencies in equipment cleaning and maintenance, including leaks and stagnant liquids, and a failure to properly investigate quality events like mold growth. Additionally, the firm lacked adequate controls for electronic data integrity, specifically regarding the review of raw data, audit trails, and chromatography test injections.