Facilities & Utilities

FDA Warning Letter: Signature Formulations cited for systemic cross-contamination and quality system failures

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FDA states that laboratory testing of (b)(4) lots of contract-manufactured (b)(4) drug products found contamination in every lot tested, including undeclared (b)(4) above the stated limit of quantitation and, in many cases, at far higher levels. The agency linked the findings to manufacturing (b)(4) products in the same environment on shared equipment. FDA said residues from the active ingredients would not be adequately removed from shared surfaces and equipment under standard cleaning conditions and that the firm had not established appropriate design and control procedures to prevent hazardous cross-contamination. Because contamination was confirmed across all randomly sampled lots, FDA characterized the problem as systemic, nonuniformly distributed, and not resolvable through retrospective testing. FDA also cited insanitary conditions, ineffective management oversight, and a quality unit lacking sufficient authority or implementation of its responsibilities. FDA recommended recall of all distributed drug products; the firm verbally committed to halt manufacturing and distribution and recall all (b)(4) drug products. FDA also noted a 2025 recall for contamination.

EU GMP Non-Compliance: Glukem Biocare Private Limited – contamination risk in cleaned fluid-bed coating equipment

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After the inspection ending 15 September 2026, the Malta Medicines Authority considered the site non-compliant for non-sterile pellet manufacture and quality-control testing. A critical deficiency concerned contamination risk in cleaned fluid-bed coating equipment: liquid pooling and residue were observed in an inlet-air plenum. The authority linked this to a design that prevented gravity drainage and an inadequate cleaning procedure. There was also no real-time differential-pressure monitoring before and after the supply-air HEPA filter to detect integrity failure. Eleven major findings covered production records, process and cleaning validation, differential-pressure excursions, warehouse, sampling and dispensing controls, vendor qualification, starting-material identification, excipient risk assessments, OOS handling, equipment qualification and pest control. The authority stated that no site-manufactured batches should be released to EEA markets while the statement remains in place, unless superseded by an EU GMP certificate. Under the revocation heading, it recommended that member states consider not initiating or authorising new marketing authorisations listing the site; it did not state that existing authorisations were revoked. The authority said products should not be present in EEA markets and did not propose a teleconference.

FDA Warning Letter: KDC/ONE Chatsworth cited for testing, OOS investigation, and storage deficiencies

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FDA inspected KDC/ONE Chatsworth’s drug manufacturing facility from March 31 to April 3, 2026, and cited significant CGMP violations involving OTC finished pharmaceuticals. The agency states that the firm lacked scientifically sound finished-product specifications and did not perform specified contaminant testing at release or during stability studies, despite known degradation and reaction pathways and notification of contamination linked to products recalled in Canada. FDA said the firm did not determine whether recalled batches reached the United States, assess U.S. consumer risk, identify other potentially affected batches, or demonstrate that its proposed third-party laboratory was qualified. FDA also observed inadequate investigations of viscosity OOS stability results, including insufficient root-cause determination, CAPA, specification justification, and risk assessment for distributed products. In addition, FDA found inadequate warehouse temperature monitoring and procedures, including storage above labeled conditions and internal limits. FDA considered the firm’s responses inadequate and stated that the quality unit was not able to fully exercise its authority and responsibilities.

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.