Incredible Products, SA de CV

Warning LetterOpen

Diego Lomeli Pelayo Co-Owner Incredible Products, SA de CV Calle Castellanos y Tapia No. 921 Col. Santa Maria 44350 Guadalajara , Jal. MexicoFEI 3009788529Issued May 27, 2021Center for Drug Evaluation and Research

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3009788529.

Violations3

Issue DateMay 27, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Incredible Products, SA de CV
Location: Diego Lomeli Pelayo Co-Owner Incredible Products, SA de CV Calle Castellanos y Tapia No. 921 Col. Santa Maria 44350 Guadalajara , Jal. Mexico
FEI Number: 3009788529
Country: Mexico
Issue Date: May 27, 2021
Issuing Office: Center for Drug Evaluation and Research
Product Type: Drugs
Status: Open

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.

Incredible Products, SA de CV FDA Warning Letter, May 27, 2021