Ideal Implant Incorporated – FDA Warning Letter, Feb 3, 2020

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