Mr. Daniel Alberto Alfaro Saldaña
DEPQ Internacional S. de R.L de C.V.
Prol. Calzada de Guadalupe 2830-A Col. Satélite Fco. I. Madero
78380 San Luis Potosí , S.L.P.
MexicoFEI 3016788198Issued Mar 18, 2021Center for Drug Evaluation and Research
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 3016788198.
Violations2
Issue DateMar 18, 2021
Product TypeDrugs
StatusOpen
Letter Details
Firm
DEPQ Internacional S. de R.L de C.V.
Location
Mr. Daniel Alberto Alfaro Saldaña
DEPQ Internacional S. de R.L de C.V.
Prol. Calzada de Guadalupe 2830-A Col. Satélite Fco. I. Madero
78380 San Luis Potosí , S.L.P.
Mexico
FEI Number
3016788198
Country
Mexico
Issue Date
March 18, 2021
Issuing Office
Center for Drug Evaluation and Research
Product Type
Drugs
Status
Open
Summary
DEPQ Internacional S. de R.L de C.V., a Mexican drug manufacturer, was warned for manufacturing three hand sanitizer products (Cleanhumans Hand Sanitizer, dgreen ADVANCED HAND SANITIZER ANTIBACTERIAL GEL, and dgreen ADVANCED HAND SANITIZER Alcohol Free) that were adulterated due to subpotency—meaning their active ingredient strength fell below claimed levels—and violated Current Good Manufacturing Practice (CGMP) requirements. The products were also unapproved new drugs introduced into U.S. interstate commerce without required FDA approval and were misbranded. FDA testing of batches detained at the U.S. border confirmed these compliance failures related to product strength, purity, and quality assurance deficiencies.
DEPQ Internacional S. de R.L de C.V. FDA Warning Letter, March 18, 2021
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