Safe Chain Solutions, LLC

Warning LetterClosed

Mr. Charles D. Boyd Founder and Chief Executive Officer Safe Chain Solutions, LLC 822 Chesapeake Drive Cambridge , MD 21613-9408 United StatesFEI 3009729473Issued Jun 8, 2023Division of Pharmaceutical Quality Operations I

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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 3009729473.

Violations4

Issue DateJun 8, 2023

Product TypeDrugs

StatusClosed

Closeout LetterMar 17, 2025

Letter Details

Firm: Safe Chain Solutions, LLC
Location: Mr. Charles D. Boyd Founder and Chief Executive Officer Safe Chain Solutions, LLC 822 Chesapeake Drive Cambridge , MD 21613-9408 United States
FEI Number: 3009729473
Country: United States
Issue Date: June 08, 2023
Issuing Office: Division of Pharmaceutical Quality Operations I
Product Type: Drugs
Status: Closed
Closeout Letter: March 17, 2025

Summary

Safe Chain Solutions, LLC, a wholesale drug distributor, violated the Drug Supply Chain Security Act (DSCSA) by failing to maintain adequate verification systems for prescription drug products and engaging in transactions with unauthorized trading partners. During an FDA inspection of the Cambridge, Maryland facility from April to May 2022, investigators found the company did not maintain proper records of suspect product investigations and failed to respond to notifications of illegitimate products as required. These violations compromised the security of the pharmaceutical supply chain and exposed patients to potential risks from counterfeit, stolen, contaminated, or harmful drugs.

Safe Chain Solutions, LLC FDA Warning Letter, June 8, 2023