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

Source: https://www.keypedia.com/records/warning_letter/ideal-implant-incorporated/fa3cc215-824c-40ab-8274-ee0402045279

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

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## Details

- Record Type: WARNING_LETTER
- Company Name: Ideal Implant Incorporated
- Inspection Date: 2020-02-03
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: The FDA issued a Warning Letter to Dr. Hamas following an inspection of their Dallas, Texas facility from January 27 to February 3, 2020. The inspection revealed that the IDEAL IMPLANT Saline-Filled Breast Implant is an adulterated device under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required information under 21 U.S.C. § 360i and 21 CFR Part 803.

Key violations include:
1.  **Failure to maintain complaint files and procedures (21 CFR 820.198(a))**: The firm did not document complaint investigations and medical device reportability evaluations for complaints 19-0233 and 18-0095. The adequacy of the firm's responses was undetermined, as the revised "Complaint Files" procedure did not address "cancelled" complaints, and evidence of a retrospective review of all complaints was not provided.
2.  **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: The firm failed to document corrective actions for sterilization load rejections

## Related Documents

- [483 - 2020-02-03](https://www.keypedia.com/records/483/ideal-implant-incorporated/19af0024-6b7e-4fdb-a222-6e044675cdc0)

## Related Officers

- [Director](https://www.keypedia.com/people/binita-s-ashar/5a2f78e1-1ad7-4bf2-b980-eb925e2c765e)
- [Program Division Director](https://www.keypedia.com/people/shari-j-shambaugh/aaea1185-eca8-41f8-bec7-d5d0024b582d)

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

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7