# FDA 483 - Implant Direct Sybron Manufacturing LLC - May 12, 2021

Source: https://www.globalkeysolutions.net/records/483/implant-direct-sybron-manufacturing-llc/4984495c-31c6-418f-b74d-68b508e28ab9

> FDA 483 for Implant Direct Sybron Manufacturing LLC on May 12, 2021. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Implant Direct Sybron Manufacturing LLC
- Inspection Date: 2021-05-12
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Implant Direct Sybron Manufacturing LLC in Thousand Oaks, CA, a medical device manufacturer, was cited for inadequate documentation of corrective and preventive action activities. The firm failed to properly document corrective actions for multiple in-process non-conformances related to labeling and packaging issues, including part mix-ups and missing components. This indicates a significant lapse in their quality system regarding CAPA implementation and record-keeping.

## Related Documents

- [483 - 2019-12-02](https://www.globalkeysolutions.net/records/483/implant-direct-sybron-manufacturing-llc/a6adc243-853e-46e4-87e2-8918671630d1)

## Related Officers

- [Kelvin Cheung](https://www.globalkeysolutions.net/people/kelvin-cheung/ded61aee-4b4b-4049-a67c-19d971475be7)

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