Incredible Products, SA de CV Warning Letter Details

Summary

Incredible Products, SA de CV was cited for manufacturing GELBACT ANTIBACTERIAL HAND GEL, an unapproved antiseptic hand sanitizer that violated multiple FDA regulations including being adulterated due to substitution of active ingredients and failing to meet Current Good Manufacturing Practice (CGMP) quality assurance standards. The product was detained at the U.S. border following FDA laboratory testing that confirmed the adulteration and demonstrated the company's quality control deficiencies. The hand gel was also found to be misbranded and introduced into interstate commerce without the required FDA approval as a new drug.