Aurelio Nembrini
General Manager
Laboratorio Pharma International SRL
Pharma Internacional Bldg, Main Street, Colonia Los Angeles
Tegucigalpa ,
11101
Honduras
anembrini@pdpharmaintusa.comFEI 3012015184Issued Sep 15, 2021Center 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 3012015184.
Violations4
Issue DateSep 15, 2021
Product TypeDrugs
StatusOpen
Letter Details
Firm
Laboratorio Pharma International SRL
Location
Aurelio Nembrini
General Manager
Laboratorio Pharma International SRL
Pharma Internacional Bldg, Main Street, Colonia Los Angeles
Tegucigalpa ,
11101
Honduras
anembrini@pdpharmaintusa.com
FEI Number
3012015184
Country
Honduras
Issue Date
September 15, 2021
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Drugs
Status
Open
Summary
Laboratorio Pharma International SRL, an over-the-counter drug manufacturer in Honduras, violated current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated drug products that failed to meet appropriate standards of identity, strength, quality, and purity. The facility specifically failed to establish adequate laboratory controls including scientifically sound specifications, standards, sampling plans, and test procedures for components, containers, closures, and finished products. Additionally, the company's product GELAZUL Topical Analgesic was distributed as an unapproved new drug and was misbranded in violation of federal law, making its introduction into interstate commerce prohibited.
Laboratorio Pharma International SRL FDA Warning Letter, September 15, 2021
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