Allergan, Ideal Implant Issued Warning Letters From FDA Related to Breast Implants
May 14 2020 - 4:48PM
Dow Jones News
By Allison Prang
Allergan and Ideal Implant Inc., manufacturers of breast
implants, were issued warning letters from the U.S. Food and Drug
Administration, the regulator said, for not complying with
regulations.
The FDA said Allergan, which is now owned by AbbVie, didn't do
post-approval studies to evaluate the risks and safety on a
long-term basis for two implant models. The implants were recalled
last year, the FDA said.
The regulator said its letter to the company mentioned "several
serious deficiencies in the manufacturer's post-approval study" for
two types of implants: its Round Responsive implants and Style 410
implants.
Ideal Implant didn't meet "good manufacturing practice
requirements and adverse event reporting requirements," the FDA
said.
The FDA's letter to Ideal Implant pointed out that the company
didn't keep "proper files for device complaints," and also didn't
have "appropriate procedures for implementing corrective and
preventive actions." The regulator said the company didn't
"maintain adequate criteria for testing finished devices."
The regulator asked both companies to respond within 15 workdays
of being issued the its letters.
Write to Allison Prang at allison.prang@wsj.com
(END) Dow Jones Newswires
May 14, 2020 16:33 ET (20:33 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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