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MarketScreener Homepage  >  Equities  >  Nyse  >  AbbVie Inc.    ABBV

ABBVIE INC.

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Allergan, Ideal Implant Issued Warning Letters From FDA Related to Breast Implants

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05/14/2020 | 05:34pm EDT

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

 


Stocks mentioned in the article
ChangeLast1st jan.
ABBVIE INC. 0.04% 84.34 Delayed Quote.-4.74%
ALLERGAN PLC 0.02% 193.02 Delayed Quote.0.97%
BYD COMPANY LIMITED -6.66% 135.9 End-of-day quote.249.81%
THE NEW HOME COMPANY INC. 0.60% 5.06 Delayed Quote.8.58%
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Financials (USD)
Sales 2020 45 372 M - -
Net income 2020 9 839 M - -
Net Debt 2020 74 016 M - -
P/E ratio 2020 16,5x
Yield 2020 5,85%
Capitalization 149 B 149 B -
EV / Sales 2020 4,91x
EV / Sales 2021 3,98x
Nbr of Employees 47 000
Free-Float 98,5%
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Mean consensus BUY
Number of Analysts 20
Average target price 109,25 $
Last Close Price 84,34 $
Spread / Highest target 50,6%
Spread / Average Target 29,5%
Spread / Lowest Target 13,8%
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Managers
NameTitle
Richard A. Gonzalez Chairman & Chief Executive Officer
Michael E. Severino Vice Chairman & President
Azita Saleki-Gerhardt Executive Vice President-Operations
Robert A. Michael Chief Financial Officer & Executive Vice President
Thomas J. Hudson Chief Scientific Officer, Senior VP-R&D
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