FDA warns Sterling Distributors for multiple DSCSA violations tied to investigating suspect products
The US Food and Drug Administration (FDA) recently issued its third warning letter under the Drug Supply Chain Security Act (DSCSA) to Florida-based Sterling Distributors for multiple violations, including failing to properly investigate suspect products, not responding to requests for an investigation, and for conducting transactions with unauthorized trading partners.The warning letter, dated 5 June 2025, stemmed from a three-day inspection conducted in early March.
This is the third warning letter of its kind issued to a wholesaler for violations of DSCSA since the law went into effect in 2013. The first was sent to McKesson in 2019 for distributing illegitimate drugs to pharmacies; the second was sent to Safe Chain Solutions in 2023 for distributing counterfeit drugs. (RELATED: FDA Warns McKesson for Distributing Illegitimate Products, Regulatory Focus 12 February 2019)
The first violation involved engaging in the wholesale distribution of prescription drug products without having the necessary licenses in Florida, Arkansas, and Mississippi.
Another violation was failing to respond to requests for information from federal and state officials. Under DSCSA, a wholesale distributor must respond to a request from federal or state officials regarding a suspect or illegitimate products within one business day.
For example, as part of its investigation into potentially suspect or illegitimate products identified at a pharmacy in Arkansas, the Arkansas Board of Pharmacy (BoP) issued a subpoena to Sterling in November 2024 requiring the company to produce records of purchase information for all products sold or shipped into Arkansas since November 2022. Sterling failed to show that it responded to the initial inquiry or to the Arkansas BoP's follow-up subpoena in January 2025.
After Sterling’s non-response, the Arkansas BoP suspended Sterling’s Arkansas medical gas license.
FDA also said the firm failed to promptly conduct an investigation with its trading partners to determine where a suspect product was illegitimate.
In December 2024, Sterling was notified by one of its trading partners, a dispenser, of concerns that it had received “mispackaged” products from Sterling after the product was returned to the dispenser by a patient. At that point, Sterling was obligated to promptly conduct the investigation yet failed to do so.
After reviewing the photos of the returned product, the manufacturer determined that it was counterfeit and illegitimate. The dispenser sent the product back to Sterling in December 2024. “This action required Sterling to promptly conduct the investigation specified in 582(c)(4)(A)(i)(II). However, Sterling failed to do so. Instead, they returned the product to their supplier, [redacted], without conducting their own investigation.”
FDA said that “Sterling’s actions are especially concerning” and that “counterfeit [redacted] has been the subject of multiple FDA and [redacted] consumer alerts over the past several years.”
Other violations included failing to have the necessary record-keeping systems in place to comply with DCSA, including the ability to identify and determine whether a product in its possession is a suspect product.
FDA did not accept the firm's claim that it was not informed of the potential for the products in question to be counterfeit.
The agency said that during the course of their investigations, the Arkansas and Mississippi BoPs made multiple attempts to contact Sterling regarding the product it was investigating but the company “did not respond to assist in [redacted] investigation.”
The agency told the firm it was “sending this compliance letter to Sterling because of the inherent risk to the supply chain when firms do not comply with the provisions of the DSCSA.”
The company was given 15 days to respond to the observations cited in the warning letter.
Sterling warning letter
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