AcousticSheep LLC – FDA 483, Nov 6, 2018

An FDA inspection of AcousticSheep LLC, a medical device specification developer and repackager/relabeler, was conducted from October 30 to November 6, 2018. The inspection resulted in the issuance of an FDA Form 483, identifying several critical deficiencies in the company's quality management system, addressed to CEO Wei-Shin Lai.

The main violations centered on the absence of adequately established and implemented written standard operating procedures (SOPs). Specifically, inspectors observed that complaint files were not adequately maintained due to a lack of SOPs for complaint handling and Medical Device Reporting. Furthermore, the company had not established formal written procedures for essential process controls to ensure product conformity, nor for corrective and preventive actions (CAPA) to address and prevent quality issues. A significant finding was also the complete lack of established written design control procedures, a fundamental requirement for medical device development.

These observations indicate a non-compliance with the regulatory framework governing medical device manufacturers under the Federal Food, Drug, and Cosmetic Act. AcousticSheep LLC is required to address these inspectional observations by providing a comprehensive response outlining their objections or, more commonly, detailing the corrective actions taken or planned to bring their operations into full compliance with quality system requirements.