Supplier Qualification

Centric Compounding Recalls Six Injectable Lots for Elevated Endotoxin

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Centric Compounding voluntarily recalled six lots of compounded Glutathione 200 mg/mL, Myer’s Cocktail, and Tri-Immune Boost injectable products to the consumer level after finding that they were compounded with Glutathione API containing elevated endotoxin levels. The affected products are 30 mL multidose vials distributed nationwide to patients and prescribers. The company reported nine accounts of symptoms including fever, chills, chest pain, nausea/vomiting, headache, and/or malaise. It warned that injectable products with elevated endotoxin could cause serious events, including hypotension, inflammatory reactions, anaphylactic shock, and death. Customers are being notified, replacements arranged, and consumers instructed to stop using and discard affected vials.

FDA Warning Letter: Happy Farm Botanicals cited for component testing, stability, and validation failures

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FDA states that its March 30 to April 2, 2026, inspection of Happy Farm Botanicals’ OTC drug facility found significant CGMP violations. The firm did not perform specific identity testing on incoming raw materials and components, including APIs, before use; one API lot received only organoleptic testing and was used in finished batches. FDA also found a lapsed supplier requalification and no adequate validation of supplier test analyses. The stability program lacked adequate chemical and microbiological support for labeled expiry periods: accelerated studies lacked controlled humidity records, several timepoints were unavailable, and failing viscosity results in accelerated and long-term studies were not investigated. FDA’s quality unit findings included absent process validation for OTC products, absent cleaning validation for non-dedicated equipment, inadequate investigation and CAPA for recurring gasket seal failures, and inappropriate API content release limits. FDA deemed the firm’s response inadequate and noted that process and cleaning validation commitments from the 2024 inspection remained incomplete. The firm reported plans to cease production of the specified drugs at this facility.

2024 PDA/FDA Conference Focuses on Effective Quality Systems

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FDA and the Parenteral Drug Association (PDA) will host the 33rd Joint Regulatory Conference on September 9–11, 2024, emphasizing effective quality systems and an ongoing state of control across the product lifecycle. The program focuses on robust quality systems, facilities, processes, raw material quality, supplier relationships, industrial modernization, and quality risk management as foundations for CGMP compliance. It will use case studies to address sustainable compliance, quality and supply consistency, and international collaboration. Planned discussion topics include investigations, cybersecurity and data integrity risks, supplier selection and auditing, current manufacturing technologies, CGMP guidance updates, aging facilities, quality assurance authority, and quality-control laboratory risk reduction.

FDA Warning Letter: Suretec Innovations cited for component, microbiological, and quality-unit controls

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FDA states that its March 2–5, 2026, inspection of Suretec Innovations’ Arizona facility found significant CGMP violations in OTC drug manufacturing. The firm did not adequately identity-test incoming components, including the API, and relied on supplier certificates of analysis without establishing their reliability. FDA also found inadequate finished-product microbiological testing: the non-compendial method lacked appropriate incubation times, method suitability, controls, and validation. The quality unit did not thoroughly investigate microbial out-of-limit results from a system supplying a manufacturing component; material from that system continued to be used in products that were released. FDA further found that the quality unit lacked adequate authority and oversight, including for production and process procedures, system qualification, stability testing, defined quality-unit responsibilities, and sufficient qualified personnel. FDA judged the firm’s responses inadequate because they lacked key documentation, implemented investigation controls, and retrospective assessments of distributed product quality. FDA requested material-system and supplier reviews, component and retain-sample testing, investigation remediation, risk assessment, CAPA, and comprehensive quality-unit remediation.