USFDA 483 Flags Dupont for Lapses in Avicel Excipient Manufacturing

USFDA issues Warning letter to DuPont Nutrition USA Inc., Newark, Delaware facility (FEI 3013947845) for significant deviations in GMP in the manufacture of excipient Avicel. Deviations cited related to Complaints Handling, OOS investigation, Method Validation, Change Management and Data Integrity 

• Handling of Complaints is Inadequate. Even though the Firm received several
  complaints of conductivity failure, it failed to timely investigate the complaints, communicate the issue to other customers and failed to take timely actions.
• Investigations into OOS (Out of specifications), identification of root cause and CAPA and impact evaluation was inadequate.
• Failed to ensure suitability of test methods, non compendial methods were not adequately validated and compendial methods were not verified. The practice of evaluating composite samples to test and release batches even when individual samples is concerning
• Change Management programs were inadequate. Monitoring of critical quality parameters were removed without documented change control
• Control over laboratory test records were inadequate. Records were backdated, failing results were changed to passing and the records were incomplete as it did not include details of sample weight, reagents used and instruments used

USFDA Warning letter to Dupont (December 2022)