Chiron Cuts Supply of Flu Vaccines Made in Germany; Liverpool Plant Under Inspection
Chiron Corporation (Emeryville, CA,
http://www.chiron.com/) announced that quality problems at its Marlburg, Germany, manufacturing plant will prevent the company from supplying its
"Begrivac" influenza virus vaccine to non-US markets for the 2005–2006 flu season. The announcement came while a US Food and
Drug Administration (Rockville, MD,
http://www.fda.gov/) reauthorization inspection was still underway at the company's Evans Vaccines plant (Speke, Liverpool, UK). This plant manufactures
the "Fluviron" influenza vaccine that was pulled from the shelf last year because of CGMP-related issues.
Chiron expected to supply 12 million doses of the Begrivac vaccine to primarily German and UK markets. The company had previously
announced that it had uncovered a small number of Begrivac vaccine lots that did not meet product sterility specifications.
In this announcement, Chiron predicted that the time required to conduct any further testing or finding any additional manufacturing
or regulatory problems as a result of the investigation could force the company to stop its supply of the vaccine.
Chiron is still expecting to produce 18–26 million doses of the Fluviron vaccine (a vast majority of which are bound for the
United States) for the 2005–2006 flu season, pending the FDA on-site inspection of its Liverpool facility. Once inspections
are completed, Chiron expects to respond to any observations noted by FDA. The company must also receive supplemental approvals
for changes to the product and its manufacturing process from the UK Medicines and Healthcare Products Regulatory Agency and
from FDA, respectively.
Able Labs Files for Chapter 11
Able Laboratories (Cranbury, NJ,
http://www.ablelabs.com/) filed for voluntary Chapter 11 reorganization in the New Jersey division of the United States Bankruptcy Court in July.
This announcement comes on the heels of the resignation of company President and interim CEO Robert G. Mauro.
In Late May, the company was forced to halt all production and recall all available product after an internal investigation
turned up problematic testing procedures.
The Chapter 11 filing will allow Able to continue as a company while working with FDA to improve the aforementioned failings,
and cover all expenses to vendors and suppliers.
In early July, Able accepted the resignation of company President and interim CEO Robert G. Mauro. Mauro's resignation
comes only a few months after he replaced Dhananjay G. Wadekar as chief executive.
According to a statement posted on the company's Web site, the company is "seeking an appropriate replacement to lead the
company in addressing the company's previously disclosed regulatory issues, including its recall of all products and its suspension
of all manufacturing operations." In the interim, Able's board of directors will oversee day-to-day activities carried out
by the senior management team.
Able also received a list of inspectional observations (Form 483) from FDA. Citations include: failure to ensure that
all drug product distributed had the safety, identity, quality, and purity that they are represented to possess; failure to
reject drug products that failed to meet established standards, specifications, and quality control criteria; and omitting
from the annual report information about investigations that may have affected FDA drug approval. Able stated that it intends
to work with FDA to resolve the outstanding regulatory issues, and "is evaluating all potential strategic options available
to it in light of the regulatory and financial issues it faces, including the possibility of seeking relief under the bankruptcy
In response to the Form 483, Able stated that it had submitted possible terms for a consent decree to FDA on May 26, and
is "prepared to enter discussions toward a decree at FDA's earliest convenience."
On June 17, the Food and Drug Administration's Cincinnati office issued a warning letter to Pragmatic Materials, Inc. (Solon,
OH), a company that repackages active pharmaceutical ingredients (APIs) for sale to pharmacies for compounding.