# FDA 483 - WCM Waste & Compliance Management Inc - March 21, 2019

Source: https://www.globalkeysolutions.net/records/483/wcm-waste-compliance-management-inc/5726467f-409c-4efe-8fdb-bc1d78a57ccc

> FDA 483 for WCM Waste & Compliance Management Inc on March 21, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: WCM Waste & Compliance Management Inc
- Inspection Date: 2019-03-21
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of WCM Waste & Compliance Management Inc in Carlsbad, CA, a manufacturer of the Class II Isolyzer/SMS sharps container device, revealed significant deficiencies in their quality system. Observations included uncontrolled production processes, uncalibrated equipment, and a lack of established procedures for rework, complaint handling, quality audits, and Medical Device Reporting (MDR). The firm also failed to adequately evaluate and approve key component vendors.

## Related Officers

- [Sara M. Richardson](https://www.globalkeysolutions.net/people/sara-m-richardson/460de568-e9ad-49bd-bf63-291bea7731db)

Company: https://www.globalkeysolutions.net/companies/wcm-waste-compliance-management-inc/b80a4b73-f55f-4b75-87bf-8c5f9fb46392

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6