FDA Terminates Class II Recall for Calvin Scott & Company's Diethylpropion Due to Repackaging cGMP Failures
Calvin Scott & Company, Inc. faced a Class II FDA recall for Diethylpropion 25 mg tablets, terminated April 22, 2024. The recall stemmed from critical cGMP deviations, specifically repackaging into pouches without supporting stability studies. This event underscores the imperative for robust quality agreements and rigorous oversight of third-party repackaging operations to mitigate supply chain and regulatory risks for procurement and regulatory affairs teams.
What the FDA Found: Critical cGMP Deviations in Diethylpropion Repackaging
The U.S. Food and Drug Administration (FDA) initiated a Class II recall, D-0009-2021, for Diethylpropion, 25 mg tablets, distributed by Calvin Scott & Company, Inc. of Albuquerque, New Mexico. This recall, voluntarily initiated by the firm on September 16, 2020, and officially terminated on April 22, 2024, was classified due to significant current Good Manufacturing Practice (cGMP) deviations. Specifically, the firm repackaged the drug product into pouches without conducting the necessary stability studies to support these new packaging configurations. For procurement directors and supply chain VPs, this means a fundamental failure in quality assurance. Repackaging without stability data directly compromises the assurance that the drug product maintains its identity, strength, quality, and purity throughout its shelf life when stored in the new packaging. This deficiency introduces an unacceptable risk of product degradation, reduced efficacy, or the formation of harmful impurities, directly impacting patient safety and the commercial viability of the distributed lots. Regulatory affairs heads must recognize this as a clear violation of 21 CFR 211.166, which mandates comprehensive stability testing programs. The absence of such data indicates a systemic gap in Calvin Scott & Company's quality management system, posing significant compliance risks for any entity relying on their repackaging services.
Operational Impact: Calvin Scott & Company's Role and Distribution Network
Calvin Scott & Company, Inc., located at 209 Eubank Blvd Ne, Albuquerque, NM 87123-2745, functioned as a distributor and repackager for Diethylpropion, 25 mg tablets. The original manufacturer of the recalled product was Lannett Company, based in Philadelphia, PA 19136. This distinction is crucial for business development executives and procurement teams: while Lannett manufactured the active pharmaceutical ingredient (API) and initial dosage form, Calvin Scott & Company introduced the critical cGMP deviation during the repackaging process. The recalled lots included CS19311, CS19337 (Exp 12/20); CS20018B, CS20019, CS20037, CS20075, CS20076, CS20112, CS20169 (Exp 8/21); CS20168 (Exp 12/21); CS20199 (Exp 5/22); and CS20243 (Exp 7/22), indicating a broad range of affected product distributed over time. The repackaged Diethylpropion was distributed to 12 physician consignees across five U.S. states: California (CA), Idaho (ID), Illinois (IL), Oklahoma (OK), and Rhode Island (RI). This targeted distribution to medical professionals highlights the direct patient exposure risk and the potential for immediate clinical impact. For supply chain VPs, this event underscores the necessity of robust oversight not just for primary manufacturers but for all downstream partners involved in any stage of drug handling, including repackaging and distribution, to ensure consistent product quality and regulatory compliance across the entire supply chain.
Supply Chain Implications: Risks for Physician Consignees and Procurement Teams
The Class II recall of Diethylpropion, 25 mg tablets, from Calvin Scott & Company, Inc. carries significant implications for physician consignees and procurement teams within the healthcare supply chain. For the 12 physician consignees in California, Idaho, Illinois, Oklahoma, and Rhode Island, this event necessitated immediate action to identify, quarantine, and return affected product, disrupting patient care and potentially eroding patient trust. Business development executives must consider the reputational damage associated with distributing products subject to recall due to fundamental quality failures. For procurement directors, this incident highlights the critical importance of rigorous due diligence when selecting and managing third-party repackaging and distribution partners. Relying on a firm that fails to conduct essential stability studies for repackaged drugs introduces unacceptable risks, including the potential for purchasing and distributing sub-potent or degraded medication. This can lead to increased product returns, legal liabilities, and significant costs associated with managing a recall. Supply chain VPs must ensure that quality agreements with all partners explicitly detail cGMP responsibilities, including requirements for stability testing for any changes in packaging configuration, to prevent similar disruptions and safeguard product integrity from the point of manufacture to patient administration.
Ensuring Product Integrity: Strategies for Sourcing and Repackaging Oversight
In light of the Calvin Scott & Company recall, procurement teams and regulatory affairs heads must re-evaluate their strategies for sourcing and overseeing repackaging operations for molecules like Diethylpropion. Given the absence of specific alternative suppliers in the knowledge graph, the focus shifts to robust qualification processes. Procurement directors should mandate that any potential repackaging partner provide comprehensive stability data for all proposed packaging configurations, demonstrating compliance with 21 CFR 211.166. This includes accelerated and long-term studies under various environmental conditions relevant to the product's distribution and storage. Regulatory affairs teams must ensure that quality agreements with repackagers are not merely contractual but are living documents that detail specific cGMP responsibilities, audit rights, and clear lines of communication for quality deviations. For business development executives, ensuring partners adhere to these stringent standards is paramount for maintaining market access and brand reputation. Diversifying the supplier base for repackaging services, where feasible, can also mitigate risks associated with a single point of failure. This proactive approach minimizes exposure to regulatory actions, supply disruptions, and potential patient harm, securing the integrity of the pharmaceutical supply chain for critical medications.
Regulatory Resolution and Future Outlook for Calvin Scott & Company
The FDA's termination of recall D-0009-2021 on April 22, 2024, for Calvin Scott & Company, Inc.'s Diethylpropion, 25 mg tablets, signifies that the agency is satisfied the firm has completed all necessary actions to remove the affected product from the market and address the underlying cGMP deviations. For regulatory affairs heads, this termination indicates a formal closure of the immediate recall event, but it does not erase the regulatory history. The firm would have been required to submit detailed reports on the recall's effectiveness, the disposition of recalled product, and corrective and preventive actions (CAPA) taken to prevent recurrence of repackaging without stability data. While the immediate threat of further enforcement related to this specific recall has passed, Calvin Scott & Company will likely remain under heightened FDA scrutiny. Procurement directors considering future engagements with the firm must conduct enhanced audits, focusing specifically on their updated quality systems, validation protocols for packaging, and stability testing programs. Business development executives should be aware that a Class II recall, even if terminated, can impact a company's reputation and perceived reliability, influencing future partnership opportunities. Maintaining robust cGMP compliance, particularly for outsourced activities like repackaging, remains a continuous obligation to ensure product quality and avoid future regulatory actions.