I think this is only the beginning. We can expect to see more warnings issued by the FDA for DSCSA violations.
- If you need a California Designated Representative – Wholesaler, or a California Designated Representative – 3PL, they’ll need Board-approved training to apply for their Designated Representative license application. Board-approved California Designated Representative courses: – Wholesaler Training Course – 3PL Training Course – Reverse Distributor Training Course
According to the article:
“The June 8 warning letter outlines what the FDA stated were “significant violations” of the Drug Supply Chain Security Act including:
- Failure to have clear directions and systems in place to identify and investigate suspected illegitimate products and handle accordingly.
- Failure to verify that all trading partners of the company had also reported licensure information to the FDA and then proceeding to conduct transactions with these partners who were not authorized.
- Failure to maintain records and documentation of suspected illegitimate products and subsequent investigations into them.
- Failure to properly respond after receiving a notification about an illegitimate product.”
Read the full source article: FDA warns wholesaler over counterfeit drugs – Becker’s Hospital Review
Keywords & Phrases: DSCSA violations; wholesaler; designated representative