FDA 483 - Calapro Inc Dba Calatex Inc - August 27, 2025

An FDA inspection of Calatex Inc., an initial importer of Class II condoms in Santa Ana, CA, revealed two significant issues. The firm failed to establish adequate procedures for purchasing controls and did not properly implement its corrective and preventive action (CAPA) procedures, including verifying the effectiveness of past CAPAs. This CAPA deficiency was a repeat observation from a previous inspection.