# FDA 483 - Implant Direct Sybron Manufacturing LLC - December 02, 2019

Source: https://www.globalkeysolutions.net/records/483/implant-direct-sybron-manufacturing-llc/a6adc243-853e-46e4-87e2-8918671630d1

> FDA 483 for Implant Direct Sybron Manufacturing LLC on December 02, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Implant Direct Sybron Manufacturing LLC
- Inspection Date: 2019-12-02
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Implant Direct Sybron Manufacturing LLC in Thousand Oaks, CA, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to establish and effectively implement procedures for corrective and preventive actions, leading to multiple Class II recalls for mislabeled, mispackaged, and unsterilized dental implants. Additionally, the inspection revealed inadequate procedures for medical device reporting, finished device acceptance, environmental controls in cleanrooms, and complaint handling.

## Related Documents

- [483 - 2021-05-12](https://www.globalkeysolutions.net/records/483/implant-direct-sybron-manufacturing-llc/4984495c-31c6-418f-b74d-68b508e28ab9)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/janet-pulver/d46b01cd-8c3d-4a54-bb91-843e0f94de89)
- [Investigator](https://www.globalkeysolutions.net/people/alexandria-l-capuano/f76c710a-613f-42b2-8958-1292fa329112)

Company: https://www.globalkeysolutions.net/companies/implant-direct-sybron-manufacturing-llc/56a57268-60f3-4c99-93ba-98bc06bf4f44

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