# FDA 483 - Reko Dental LLC dba MDC Dental - March 21, 2023

Source: https://www.keypedia.com/records/483/reko-dental-llc-dba-mdc-dental/fa719d67-a2ab-4cb4-922c-213a907dd25b

> FDA 483 for Reko Dental LLC dba MDC Dental on March 21, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reko Dental LLC dba MDC Dental
- Inspection Date: 2023-03-21
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Reko Dental LLC dba MDC Dental in Gardena, CA, was inspected as a Complaint File Establishment. The inspection revealed significant deficiencies in the firm's complaint handling system, including a lack of written procedures, no quality agreement with its international manufacturing site regarding complaint responsibilities, and no complaint log. These issues indicate a failure to adequately establish and maintain a system for receiving, reviewing, and evaluating complaints.

## Related Officers

- [investigator](https://www.keypedia.com/people/juanita-banuelos/b8b581ef-b9f3-4d77-a9fa-691223dbb7f4)

Company: https://www.keypedia.com/companies/reko-dental-llc-dba-mdc-dental/da72f97e-7a9a-4546-8881-dd24e40ebf14

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