DuPont Nutrition USA Inc. — FDA Warning Letter Findings
US FDAPublished 2022-12-204 findingsMaterial and supplier controlDeviation, CAPA, and investigationComplaint and recall handlingLaboratory and QC controls
Your firm failed to have an adequate change management program to evaluate and approve changes that may impact the quality of the excipient. Your Avicel process performance qualification studies conducted from 2001 through 2007 identified conductivity as a critical quality parameter. However, in approximately 2011 you removed the (b)(4) conductivity meters without a documented change control. In your response you state that at the time of the change you evaluated the…
2Deviation, CAPA, and investigation
You failed to thoroughly investigate OOS results in a timely manner, appropriately identify root causes, expand investigations to all potentially affected lots, and implement adequate CAPA. Your investigations into failing test results are inadequate. You had failing results for conductivity in Avicel lots. Your laboratory OOS results were only investigated by the original analyst using a checklist. The supervisory review did not include an evaluation of the records and test…
3Complaint and recall handling
Your firm failed to perform adequate investigation of complaints. Your firm manufactures microcrystalline cellulose (MCC) under the brand name Avicel, which is included in Drug Master File (DMF) 449 submitted to FDA. Avicel is used as a compression and flow aid in multiple drug product formulations. Between April 2020 and June 2021, you received approximately 50 complaints related to your Avicel excipient failing to meet the conductivity specifications. The conductivity…
4Laboratory and QC controls
Your firm failed to have adequate laboratory control records that include complete and accurate data from tests performed to ensure conformance with specifications and standards, nor did you record activities at the time of performance. During the inspection, your laboratory personnel backdated the approval section of an in-house microbiological media preparation worksheet after the media had been used. In addition, your microbiology laboratory personnel were observed using…
About this record
Extracted automatically from the document US FDA published on 2022-12-20. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
