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# QS, MDR Violations at Ideal Implant
- URL: https://www.fdaweb.com/qs-mdr-violations-at-ideal-implant/
- Published: 2020-05-14T12:00:00.000Z
- Updated: 2026-09-14T16:14:55.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146793

A 1/27-2/3 FDA inspection at Ideal Implant Inc., a Dallas, TX, manufacturer of the Ideal Implant saline-filled breast implant, identified Quality System Regulation and Medical Device Reporting violations. A 5/14 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ideal-implant-incorporated-606103-05142020?ref=fdaweb.com) says specific violations were:

- failing to maintain complaint files and to establish and maintain procedures for receiving, reviewing, and evaluating complaints made by a formally designated unit;
- failing to establish and maintain procedures for implementing corrective and preventive action;
- failing to establish and maintain adequate procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria;
- failing to submit a report to FDA no later than 30 days after the day that the firm received or otherwise became aware of information from any source that reasonably suggests that a device that the firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury if the malfunction were to recur; and
- failing to adequately develop, maintain, and implement written medical device reporting procedures.

FDA says the firm’s responses to the inspection observations either were inadequate or their adequacy could not be determined.

Ideal was told to take prompt action to correct the violations and to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation of each step and a timetable for completing the actions.