Chandra Kasireddy
Chief Operating Officer
BPI Labs, LLC
12393 S Belcher Road Ste 450
Largo , FL 33773
United States
chandrak@belcherpharma.comFEI 3015156709Issued Mar 20, 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 3015156709.
Violations2
Issue DateMar 20, 2025
Product TypeDrugs
StatusOpen
Letter Details
Firm
BPI Labs, LLC
Location
Chandra Kasireddy
Chief Operating Officer
BPI Labs, LLC
12393 S Belcher Road Ste 450
Largo , FL 33773
United States
chandrak@belcherpharma.com
FEI Number
3015156709
Country
United States
Issue Date
March 20, 2025
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
BPI Labs, LLC distributed Epinephrine Chloride Nasal Solution 1 mg/mL without FDA approval, violating section 505(a) of the Federal Food, Drug, and Cosmetic Act by introducing an unapproved new drug into interstate commerce. The product was also misbranded under section 502(i) of the FD&C Act, as it lacked required regulatory authorization despite being labeled with claims indicating use as a nasal decongestant and vasoconstrictor. The FDA determined the product did not meet the "generally recognized as safe and effective" (GRASE) standard required for marketing without an approved new drug application.
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