# FDA 483 - Ideal Implant Incorporated - February 03, 2020

Source: https://www.globalkeysolutions.net/records/483/ideal-implant-incorporated/19af0024-6b7e-4fdb-a222-6e044675cdc0

> FDA 483 for Ideal Implant Incorporated on February 03, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ideal Implant Incorporated
- Inspection Date: 2020-02-03
- Product Type: device
- Office Name: Dallas District Office
- Summary: Ideal Implant Incorporated, a medical device manufacturer in Dallas, TX, was inspected by the FDA from January 27 to February 3, 2020. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for complaint handling, untimely submission of Medical Device Reports (MDRs), and ineffective corrective and preventive actions. Additionally, the firm's finished device acceptance procedures were insufficient, risk analysis was incomplete, and software used in the quality system was not validated.

## Related Documents

- [WARNING_LETTER - 2020-02-03](https://www.globalkeysolutions.net/records/warning_letter/ideal-implant-incorporated/fa3cc215-824c-40ab-8274-ee0402045279)

## Related Officers

- [Tuan A Nguyen](https://www.globalkeysolutions.net/people/tuan-a-nguyen/50723bbb-29a1-4e7a-a5aa-123ec3866065)
- [issuing_officer](https://www.globalkeysolutions.net/people/roy-baby/69a18ef5-167c-41eb-a57e-3d138a0820c2)

Company: https://www.globalkeysolutions.net/companies/ideal-implant-incorporated/1f2bab20-7513-4cb6-8d4b-5629297faa98

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9