Ardil Comercial S.R.L.

Warning LetterOpen

Ms. Cecilia Ramirez Administrative Director Ardil Comercial S.R.L. Pastora Elida Km 19 No. 03, Apto. 1 11606 Santo Domingo Dominican RepublicFEI 3012644697Issued Sep 22, 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 3012644697.

Violations4

Issue DateSep 22, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Ardil Comercial S.R.L.
Location: Ms. Cecilia Ramirez Administrative Director Ardil Comercial S.R.L. Pastora Elida Km 19 No. 03, Apto. 1 11606 Santo Domingo Dominican Republic
FEI Number: 3012644697
Country: Dominican Republic
Issue Date: September 22, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Ardil Comercial S.R.L., a Dominican Republic-based drug manufacturer, was cited for manufacturing and attempting to import an unapproved hand sanitizer product (Alcohol Isopropilico Hand Sanitizer Limar) that violated multiple FDA regulations including adulteration, misbranding, and unapproved new drug status. FDA laboratory testing of a detained batch confirmed the product was adulterated because it contained substituted substances and failed to meet Current Good Manufacturing Practice (CGMP) requirements for quality assurance. The product was labeled as containing 70% isopropyl alcohol but FDA testing revealed it did not meet this specification, resulting in border detention and refusal of admission into the United States.

Ardil Comercial S.R.L. FDA Warning Letter, September 22, 2021