FDA 483 - CARLSBAD TECHNOLOGY INC - October 25, 2019

CARLSBAD TECHNOLOGY INC, a drug manufacturer in Carlsbad, CA, received a Form 483 with three observations. The inspection revealed issues with sanitation procedures not being followed, inadequate record-keeping for equipment cleaning, and a lack of routine calibration for electronic equipment used in cleaning processes. These deficiencies raise concerns about potential cross-contamination and product quality.