Driving Quality Culture to Manage Risk: Lessons from an FDA Inspection Response

At the 2026 PDA/FDA Joint Regulatory Conference, B. Timothy Bassler, SVP of Quality Operations at PCI Pharma Services, presented "Driving Quality Culture to Manage Risk," using a real-world FDA inspection case study to illustrate how quality culture and quality management systems (QMS) work together to manage compliance risk.¹ His framing message: complexity is the enemy of compliance.

Bassler opened by outlining what active, visible quality oversight looks like in practice: routine presence on the shop floor, timely review of microbiological signals, willingness to challenge weak investigations, oversight of aseptic behaviors, and escalation of unresolved risks. He emphasized that a quality unit needs sufficient authority, technical expertise, staffing, and independence to act, including the authority to halt operations when sterility assurance may be compromised. That expectation tracks with how Siegfried Schmitt has described the quality unit's role to PharmTech: it's the function that implements and owns the pharmaceutical quality system underpinning a site's compliance, separate from, and independent of, the operations it oversees.

The presentation's centerpiece was a case study drawn from PCI's May 2025 acquisition of Ajinomoto Althea's San Diego-based sterile fill-finish site.² Shortly after the acquisition closed, an FDA inspection at the site concluded on May 9, 2025, resulting in a Form 483 with multiple observations and triggering a formal remediation response.³ Bassler walked through the subsequent timeline: a July 2025 leadership meeting between FDA's Office of Manufacturing Quality and senior PCI leadership, voluntary commitments to remediate additional observations identified during that dialogue, the agency's issuance of Voluntary Action Indicated status, and ongoing status updates to FDA through completion of all committed actions. The remediation path Bassler described mirrors the pitfalls discussed during last year's PDA Regulatory Conference, when agency officials warned that companies too often propose quick fixes without thorough root-cause analysis instead of the comprehensive remediation that FDA expects.

A key theme of Bassler’s presentation was FDA's expectation that companies bring in third-party expertise to strengthen quality unit oversight, spanning audits of aseptic processing design, independent assessment of quality unit functions, and review of investigation systems for deviations, discrepancies, complaints, and out-of-specification results. Warning letters citing failures to implement effective CAPA after repeated aseptic-line failures have shown how quickly weak investigation systems escalate into agency action.

To operationalize FDA's feedback, PCI conducted a comprehensive site quality unit assessment combining document review, personnel interviews, a "voice of customer" survey, walkthroughs, mock disposition exercises, and trend analysis of quality metrics. That assessment produced seven defined actions across three workstreams: governance and authority, operational control, and capability-building for quality unit personnel.

Bassler detailed several resulting system improvements: an integrated batch disposition model embedding quality checkpoints throughout the batch lifecycle, an aseptic core monitor program providing real-time observation and peer-to-peer feedback on aseptic operations, a risk-tiered aseptic qualification framework, and a formal quality authority and decision-making matrix assigning investigation decision rights by role and risk.

Bassler closed with three takeaways: conduct a detailed current-state assessment before acting, set explicit expectations to drive process improvement, and track data continuously to sustain gains. The presentation credited PCI's San Diego Development and Manufacturing team, PricewaterhouseCoopers Advisory Services, and Network Partners Group for their roles in the remediation effort.

References

Parenteral Drug Association. PDA/FDA Join Regulatory Confernce 2026 Agenda. Available at https://www.pda.org/global-event-calendar/event-detail/pda-fda-joint-regulatory-conference-2026#agenda. Accessed Sept 15, 2026.

PCI Pharma Services. PCI Pharma Services to Acquire US-based Aseptic Fill-Finish CDMO Ajinomoto Althea. Press Release. April 24, 2025.

Redica Systems. PCI Sand Diego, Inc. – Form 483, 2025-05-09. Available at https://www.redica.com/document-store/documents/view/100221964/pci-san-diego-inc-form-483-2025-05-09. Accessed Sept 15, 2026.