Drugs

CGMP Deviations in DuPont Avicel Manufacturing

An 11/17/21-12/15/21 FDA inspection at the DuPont Nutrition USA excipient manufacturing plant in Newark, DE, found significant deviations from current good manufacturing practice (CGMP) regulations for the manufacture of its excipient Avicel, which FDA says is extensively used as a major component in a wide variety of drug products. A recently-released 12/2 Warning Letter says Avicel is adulterated for failing to conform to compendial standards for strength, quality, or purity. Specific CGMP deviations were:

failing to perform an adequate investigation of complaints;
failing to thoroughly investigate out-of-specification results on time, appropriately identify root causes, expand investigations to all potentially affected lots, and implement adequate corrective and preventive actions;
failing to ensure the test methods used are suitable for their intended use;
failing to have an adequate change management program to evaluate and approve changes that may affect the quality of the excipient; and
failing to have adequate laboratory control records that include complete and accurate data from tests performed to ensure conformance with specifications and standards, and failing to record activities at the time of performance.

FDA says DuPont’s quality control system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the excipient it manufactures. The agency recommended the company hire a qualified third-party auditor/consultant with experience in detecting data integrity problems to assist it in complying with CGMP requirements.

DuPont was told to respond with a list of specific actions it has taken to address any deviations and prevent their recurrence, with a schedule for completing the corrections.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome