# FDA 483 - Bio Protech Usa, Inc. - February 20, 2020

Source: https://www.globalkeysolutions.net/records/483/bio-protech-usa-inc/f81385aa-3e67-4dc8-893a-2ea6937a7876

> FDA 483 for Bio Protech Usa, Inc. on February 20, 2020. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Bio Protech Usa, Inc.
- Inspection Date: 2020-02-20
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Bio Protech Usa, Inc., a repackager/relabeler in Chino, CA, revealed significant deficiencies in their quality system. The firm failed to establish adequate written procedures for handling complaints, medical device reporting (MDR), and acceptance activities for finished products. Additionally, the inspection found a complete lack of established training procedures and documentation for personnel.

## Related Officers

- [Marlo-Ian M. Alintanahin](https://www.globalkeysolutions.net/people/marlo-ian-m-alintanahin/a37da927-b369-4753-b275-41743556f25e)

Company: https://www.globalkeysolutions.net/companies/bio-protech-usa-inc/2b82abd2-b0da-4769-b1f4-fd7a5203f8d3

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