Bausch & Lomb Responds to FDA Warning Letter on ReNu
Bausch & Lomb Receives FDA Warning Letter on ReNu related to Inspection
at Greenville, S.C. Solutions Manufacturing Plant conducted in March-May
2006
FOR RELEASE MONDAY, NOVEMBER 6, 2006
ROCHESTER, N.Y. –
Bausch & Lomb (NYSE: BOL) today announced that it has received a Warning
Letter from the United States Food and Drug Administration relating to an
inspection the agency conducted at the Company’s Greenville, S.C. solutions
manufacturing plant during the period March 22 through May 15, 2006 in
connection with reports of Fusarium keratitis from some users of ReNu with
MoistureLoc solution produced in the facility. Although the inspection did not
identify any conditions at the manufacturing facility that contributed to or
caused the reported adverse events, it identified some important issues that the
Company is addressing through a series of corrective actions. The Warning Letter
contains no new observations, but rather documents those corrective actions
still in process. Bausch & Lomb voluntarily initiated a global recall of its
ReNu with MoistureLoc lens care solution on May 15, 2006.
In response to
the FDA’s report on the inspection observations (FDA Form 483), the Company
immediately initiated a series of corrective actions and submitted a
comprehensive plan summarizing those actions on June 30, 2006. The Warning
Letter summarizes the agency’s assessment of the corrective actions completed as
of the Company’s June 30, 2006 response. Since that time, the Company has
continued to keep the FDA updated on its progress toward completing the
corrective actions outlined in its response to the Form 483.
At an
update with agency representatives in mid-August, the Company reported having
completed more than half of the action items. In a report submitted on October
12, which the agency has yet to finish reviewing, the Company reported that more
than two-thirds of the action items had been completed; that the majority of the
outstanding items were in the process of implementation according to schedule;
and that a handful had been assigned new completion dates. Of the unfinished
actions itemized in the Warning Letter, the great majority were reported as
complete in the October 12 update, although, of course, they cannot be
considered closed until the FDA has had the opportunity to review or inspect
them.
Bausch & Lomb said today that it has taken very seriously its
responsibility to respond with appropriate speed and thoroughness to the FDA’s
observations. The Company has confidence in the products it manufactures at the
facility based on the processes and systems in place. Bausch & Lomb is
committed to completing the remainder of the action items in its corrective plan
according to schedule, and expects to be ready for a re-inspection in the first
quarter of 2007.
### This news release contains, among other things,
certain statements of a forward-looking nature relating to future events or the
future business performance of Bausch & Lomb. Such statements involve a
number of risks and uncertainties including those concerning economic
conditions, currency exchange rates, product development and introduction, the
financial well-being of key customers, the successful execution of marketing
strategies, the continued successful implementation of its efforts in managing
and reducing costs and expenses, as well as the risk factors listed from time to
time in the Company’s SEC filings, including but not limited to filings on Form
8-K and on Form 12b-25, each dated August 8, 2006.
Bausch & Lomb is
the eye health Company, dedicated to perfecting vision and enhancing life for
consumers around the world. Its core businesses include soft and rigid gas
permeable contact lenses and lens care products, and ophthalmic surgical and
pharmaceutical products. The Bausch & Lomb name is one of the best known and
most respected healthcare brands in the world. Founded in 1853, the Company is
headquartered in Rochester, New York. Bausch & Lomb’s 2004 revenues were
$2.2 billion; it employs approximately 13,700 people worldwide and its products
are available in more than 100 countries. More information about the Company is
on the Bausch & Lomb Web site at www.bausch.com. Copyright Bausch & Lomb
Incorporated.
If you have developed an severe eye infection resulting in vision loss after using ReNu contact lens solution, you may have a lawsuit claim against the manufacturer, Bausch & Lomb. To inquire about your possible ReNu lawsuit, fill out the form below for a free case evaluation. We will be in touch shortly.
see also:
Bausch & Lomb Press Release
Bausch & Lomb Press Release: ReNu MoistureLocBausch & Lomb's Press Release about ReNu MoistureLoc and eye infection
FDA Public Health Notice
ReNu MoistureLoc Attorney - FDA Public Health NoticeFDA ReNu Advisory: Fungal Eye Infection causes vision loss, blindness
News & Warnings
ReNu Lawsuit - Bausch & Lomb’s Contact Lens Solution News & Warnings Keep up to date with ReNu Brand contact lens solution News & Warnings
