FDA 483 - Donson Machine Company, Inc. - August 18, 2025

Donson Machine Company, a contract manufacturer, underwent an FDA inspection from August 13-18, 2025, which identified several quality system deficiencies. The inspection resulted in a Form FDA-483, detailing three primary observations.

First, the company's procedures for corrective and preventive actions (CAPA) were found to be inadequate. A specific CAPA (311) concerning incorrect material grading lacked documented verification of effectiveness. The CAPA procedure itself was found to be insufficient, lacking clear documentation requirements and definitions for key terms like "Verification of Effectiveness." Additionally, a confirmed non-conforming product complaint (CMP-0957407) had not led to the initiation of a required Corrective Action Request Form.

Second, significant issues were observed in document control procedures, specifically concerning the review and approval of records. Neither calibration records for instruments, such as a micrometer, nor a sample of 11 CAPAs from the past two years showed evidence of documented quality review and approval signatures.

Finally, the inspection revealed the use of unapproved documents in production. Employees were utilizing a "Production Template Expanded" with manual, unapproved changes, and an unapproved "Tools Change Sheet for the Machine" form for documenting tool changes.

These observations indicate a need for Donson Machine Company to enhance its adherence to quality system regulations, as outlined under the Federal Food, Drug, and Cosmetic Act. The company committed to correcting all identified issues by September 12, 2025, highlighting its responsibility for thorough internal self-audits and corrective measures.