Subscribe to RSS - FDA

FDA

Invacare shifts production

 - 
02/19/2013

ELYRIA, Ohio – Employees in some departments at Invacare’s Taylor Street facility will soon work three-day instead of five-day shifts, according to an article from The Morning Journal, a newspaper based in Lorain, Ohio.

Will agreement dampen sales at Invacare?

 - 
02/15/2013

ELYRIA, Ohio – It may be an uphill battle for Invacare to get new customers into complex power wheelchairs under an agreement it has with the Food and Drug Administration (FDA).

Invacare sets stage for turnaround

Company plans to resume design activities mid-year
 - 
02/08/2013

ELYRIA, Ohio – Invacare officials hope they have put “one of the most challenging years in the company’s history” behind them.

Merits Health clears FDA hurdle

 - 
02/05/2013

CAPE CORAL, Fla. – Merits Health says the U.S. Food and Drug Administration (FDA) has cleared its manufacturing facility in Taiwan.

In wake of agreement, new normal for Invacare, providers

 - 
12/28/2012

ELYRIA, Ohio – A Dec. 21 agreement with the Food and Drug Administration (FDA) will limit operations at Invacare’s Taylor Street manufacturing facility, but HME providers will still have access to the manufacturer’s manual and power wheelchairs, says Gerry Blouch, president and CEO.

Invacare reduces workforce

 - 
12/27/2012

ELYRIA, Ohio – Invacare will lay off 143 employees due to a decline in production at its Taylor Street manufacturing facility here.

Invacare offloads supply division, settles with FDA

 - 
12/21/2012

ELYRIA, Ohio – In a busy week, Invacare has sold Invacare Supply Group (ISG) and reached an agreement with the Food and Drug Administration (FDA).

Invacare talks demand, FDA

‘Right now, we don’t see any need to resize the business’
 - 
10/26/2012

ELYRIA, Ohio – Invacare’s earnings call Oct. 25 included the usual discussions of the company’s negotiations with the Food and Drug Administration (FDA), but what raised the eyebrow of at least one analyst?

FDA update: Reviews, inspections and audits

 - 
10/05/2012

YARMOUTH, Maine – There’s a light at the end of the tunnel for HME manufacturers that have spent the better part of the past two years wrangling with the Food and Drug Administration (FDA).

Invacare’s earnings slide

 - 
07/27/2012

ELYRIA, Ohio – Invacare officials say a number of pressures drove a net loss of $1.98 million for the second quarter this year compared to net earnings of $10.66 million for the same period last year.

Pages