Shares of musculoskeletal major
Integra LifeSciences Holdings Corporation
) gained 9.90% (or $3.71) on Aug 15, 2013 to close at $41.17
following good news about the company's N. J. facility.
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On Aug 14, Integra disclosed that the U.S. Food and Drug
Administration (FDA) successfully completed an inspection of its
regenerative medicine facility in Plainsboro, N.J. Following the
inspection, FDA cleared the Plainsboro facility from any
Integra's Plainsboro facility was subject to an FDA warning
letter since Dec 21, 2011 following an inspection by the FDA
earlier, in the third quarter of 2011. The warning letter
pertained to quality system checks and compliance issues at the
Plainsboro facility. In mid-2012, the regenerative medicine
facility was again inspected by the FDA. However, Integra failed
to gain clearance back then.
While the warning letter did not result in any product recall or
restrict manufacturing operations at the Plainsboro facility, it
hurt revenues and gross margin throughout 2012 due to remediation
activities to obtain FDA clearance. The recent inspection
of the facility began on Jul 16, 2013. Based on the inspectional
observation, Integra's remediation activities convinced the FDA
that its quality management system at Plainsboro was adequate.
The news came as a major upside for Integra and bolstered market
sentiments as reflected in the share price movement. However, the
company is still plagued by several challenges. Among these, one
of the major setbacks is the series of voluntary product recalls
in Apr 2013. These products manufactured during Dec 2010-May 2011
and Nov 2012- Mar 2013 at its Anyasco, Puerto Rico facility,
slipped the quality standards due to deviations from an approved
Moreover, on Feb 15, 2013, Integra discontinued the distribution
of its collagen products manufactured at the Anyasco facility
following a warning letter from the FDA. The company produced
silicone and collagen offerings at the Puerto Rican facility. As
a result, Integra continues to battle higher expenses associated
with the recalls and remediation plans.
We remain watchful of further developments regarding the product
recall and its impact on Integra's financial results. The stock
carries a Zacks Rank #3 (Hold).
While we remain on the sidelines for Integra, other medical
stocks such as
Gilead Sciences Inc.
) are worth considering. These stocks carry Zacks Rank #1 (Strong