Ideal Implant has received a warning letter from the FDA for serious quality lapses, including the failure to document complaint investigations for its saline-filled breast implants.

The FDA said the company’s responses following an agency inspection of its Dallas facility were inadequate.

The agency also said the implants were misbranded because the firm had not filed required medical device reports with the FDA within 30 calendar days after becoming aware that an implant would be likely to cause or contribute to a death or serious injury.