# FDA 483 - Spectra Baby USA - November 22, 2019

Source: https://www.globalkeysolutions.net/records/483/spectra-baby-usa/63212e36-b6aa-4f02-b2b9-d14a656e7272

> FDA 483 for Spectra Baby USA on November 22, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spectra Baby USA
- Inspection Date: 2019-11-22
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Officers

- [Dianiris C. Ayala](https://www.globalkeysolutions.net/people/dianiris-c-ayala/ba6c5538-201b-4c9a-8f23-e160db6868e6)

Company: https://www.globalkeysolutions.net/companies/spectra-baby-usa/46dd95e7-c49b-44e0-a6eb-52d1894217e4

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6