Ms. Angelica Flores
Chief Executive Officer
DDI Multinacional S.A. de C.V.
Javier Espinoza No. Mz. 30 Lt 20, Col.
Santa Martha Acatitla
09510 Iztapalapa , CDMX
MexicoFEI 3012510709Issued Jun 27, 2022Center for Drug Evaluation and Research | CDER
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 3012510709.
Violations3
Issue DateJun 27, 2022
Product TypeDrugs
StatusOpen
Letter Details
Firm
DDI Multinacional S.A. de C.V.
Location
Ms. Angelica Flores
Chief Executive Officer
DDI Multinacional S.A. de C.V.
Javier Espinoza No. Mz. 30 Lt 20, Col.
Santa Martha Acatitla
09510 Iztapalapa , CDMX
Mexico
FEI Number
3012510709
Country
Mexico
Issue Date
June 27, 2022
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Drugs
Status
Open
Summary
DDI Multinacional S.A. de C.V. was warned about manufacturing unapproved hand sanitizer products (EARTHS AMENITIES Hand Sanitizer and AGAVESPA skincare HAND SANITIZER) that violated multiple sections of the Federal Food, Drug, and Cosmetic Act. FDA testing revealed the products were adulterated due to substance substitution and demonstrated that the company's quality assurance systems were not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements. The products were also misbranded and classified as unapproved new drugs, resulting in their detention and refusal of admission at the U.S. border.
DDI Multinacional S.A. de C.V. FDA Warning Letter, June 27, 2022
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