Laboratorios Jaloma S.A. de C.V.

Warning LetterOpen

Mr. Jaime Labastida Director Laboratorios Jaloma S.A. de C.V. Calle Aquiles Serdan No. 438 Col. Oblatos 44700 Guadalajara , Jal. MexicoFEI 3002600322Issued Jan 25, 2021Center for Drug Evaluation and Research | CDER

View Letter

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 3002600322.

Violations3

Issue DateJan 25, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Laboratorios Jaloma S.A. de C.V.
Location: Mr. Jaime Labastida Director Laboratorios Jaloma S.A. de C.V. Calle Aquiles Serdan No. 438 Col. Oblatos 44700 Guadalajara , Jal. Mexico
FEI Number: 3002600322
Country: Mexico
Issue Date: January 25, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Laboratorios Jaloma S.A. de C.V. was cited for manufacturing Jaloma Antiseptic Hand Sanitizer, an unapproved new drug that was adulterated due to substance substitution and failed quality assurance controls that violated Current Good Manufacturing Practice (CGMP) requirements. The product was detained and refused admission at the U.S. border following FDA laboratory testing that confirmed the adulteration. The hand sanitizer was also found to be misbranded under multiple FD&C Act sections and introduced into interstate commerce without required approval, violating sections 505(a) and 301 of the FD&C Act.

Laboratorios Jaloma S.A. de C.V. FDA Warning Letter, January 25, 2021