Mr. Sudheer Kancherla
Chief Executive Officer
Strukmyer LLC dba Strukmyer Medical
1801 Big Town Blvd. Ste. 100
Mesquite , TX 75149-1011
United StatesFEI 3000205837Issued Jan 30, 2025Center 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 3000205837.
Violations5
Issue DateJan 30, 2025
Product TypeDrugs
StatusOpen
Letter Details
Firm
Strukmyer LLC dba Strukmyer Medical
Location
Mr. Sudheer Kancherla
Chief Executive Officer
Strukmyer LLC dba Strukmyer Medical
1801 Big Town Blvd. Ste. 100
Mesquite , TX 75149-1011
United States
FEI Number
3000205837
Country
United States
Issue Date
January 30, 2025
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Strukmyer Medical, a drug manufacturer in Mesquite, Texas, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals during an FDA inspection from July-August 2024. The company failed to adequately investigate over 60 instances of objectionable microorganisms—including Burkholderia, Pseudomonas, Staphylococcus, Bacillus, and Aspergillus species—isolated from its water system used as a component in over-the-counter wound and burn care products, and did not implement sufficient corrective actions to prevent recurrence. These manufacturing control failures rendered the drug products adulterated under the Federal Food, Drug, and Cosmetic Act.
Strukmyer LLC dba Strukmyer Medical FDA Warning Letter, January 30, 2025
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