Mirta I. Riesgo, President and QC Director
Sonia Menendez, Vice President & Operations Director
Dextrum Laboratories Inc.
6993 NW 82nd Avenue Suite 20
Miami , FL 33166-2782
United States
mriesgo@detrumlabs.com
smenendez@detrumlabs.comFEI 3003092372Issued Dec 7, 2023Division of Pharmaceutical Quality Operations II
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 3003092372.
Violations4
Issue DateDec 7, 2023
Product TypeDrugs
StatusOpen
Letter Details
Firm
Dextrum Laboratories Inc.
Location
Mirta I. Riesgo, President and QC Director
Sonia Menendez, Vice President & Operations Director
Dextrum Laboratories Inc.
6993 NW 82nd Avenue Suite 20
Miami , FL 33166-2782
United States
mriesgo@detrumlabs.com
smenendez@detrumlabs.com
FEI Number
3003092372
Country
United States
Issue Date
December 07, 2023
Issuing Office
Division of Pharmaceutical Quality Operations II
Product Type
Drugs
Status
Open
Summary
Dextrum Laboratories Inc., an OTC drug manufacturer in Miami, failed to conduct required identity testing on incoming components used in cough and cold products, including dextromethorphan and glycerin, in violation of Current Good Manufacturing Practice regulations. The firm particularly failed to adequately test shipments of high-risk components susceptible to diethylene glycol or ethylene glycol contamination, rendering their drug products adulterated. These deficiencies were identified during an FDA inspection in July 2023 and documented in a warning letter issued in December 2023.
Dextrum Laboratories Inc. FDA Warning Letter, December 7, 2023
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