FDA 483 - Spectra Baby USA - November 22, 2019

Mother's Milk, Inc. dba Spectra Baby USA, an initial importer and complaint handling establishment in Davie, FL, was cited for four significant quality system deficiencies during an FDA inspection. The firm lacked essential written procedures for Medical Device Reporting, complaint handling, corrective and preventive actions, and document control. These observations indicate a fundamental absence of critical quality management systems.