Presentation · March 2026
When Risk Is Ignored: GMP Inspection Pitfalls and Compliance Impact
Ileana Barreto-Pettit, R.N., M.P.H. · Former FDA National Drug Expert
Capitana Audit Solutions LLC · Speaker
50th International GMP Conference, University of Georgia & FDA, Athens, GA
Most GMP failures stem from ignored risks. This presentation reviews major drug quality failures and the regulatory reforms each one prompted. The cases discussed include the 1937 DEG-contaminated cough syrup, thalidomide, heparin contamination, the NECC meningitis outbreak, Burkholderia cepacia in docusate sodium, and contaminated OTC eye drops.
It then examines how risk is ignored within a manufacturing site: weak quality culture indicators, decisions made without documented impact assessment, overreliance on historical performance, and a "we've always done it this way" mindset. Case studies address aseptic processing failures, data integrity weaknesses, and training and competency gaps.
Weak Quality-Culture Indicators
- Normalization of deviations: minor deviations routinely accepted as "normal"
- Fear of reporting errors and a blame-oriented environment
- Poor GMP documentation practices and data integrity gaps (ALCOA+)
- Changes made without documented impact assessment
- Lack of ownership of quality at the floor level
- Inadequate training and competency verification
- Poor cross-functional communication
- Weak management commitment to quality and hidden quality metrics
- Ineffective CAPAs: superficial root causes such as "operator error"
Impact of Ignoring Risks
- Poor product quality and high safety risk to patients
- Regulatory impact
- Operational impact: batch failures, production downtime, supply chain disruption and drug shortages, and cost of remediation
Key Takeaways
- Most GMP failures stem from ignored risks
- Proactive QRM reduces compliance exposure
- Strong quality culture is the best defense
- Inspection readiness must be continuous
Get in Touch
Prepare for U.S. FDA inspections with a former FDA National Drug Expert.
Request a Consultation