August 2005 - Pharmaceutical Technology

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August 2005

Pharmaceutical Technology


MANUFACTURING

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.

–Kaylynn Chiarello

RECALLS

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.

Another resignation 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.

Citations 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 laws."

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."

–George Koroneos

WARNING LETTER

Pragmatic Materials

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.


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