# FDA 483 - Plasdent Corporation - November 22, 2019

Source: https://www.globalkeysolutions.net/records/483/plasdent-corporation/97c8083f-6909-43c4-ace4-55c69fe4310e

> FDA 483 for Plasdent Corporation on November 22, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Plasdent Corporation
- Inspection Date: 2019-11-22
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Pladent Corporation, a repackager/relabeler in Pomona, CA, received a Form FDA 483 following an inspection that revealed significant deficiencies across its quality system. The firm lacked established procedures for labeling, complaint handling, Medical Device Reporting (MDR), and corrective and preventive actions (CAPA). Additionally, the firm failed to appoint a management representative to oversee quality system performance.

## Related Officers

- [Marlo I Alltanahin](https://www.globalkeysolutions.net/people/marlo-i-alltanahin/377a5982-f4db-4db1-8881-dece9c344f9f)

Company: https://www.globalkeysolutions.net/companies/plasdent-corporation/4e98f7b9-aa63-42db-b5f9-48775a01523d

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