ROCKVILLE, Md., Dec. 1 /PRNewswire/ -- Vintage Pharmaceuticals, Inc., a
major manufacturer of generic drugs, has agreed to bring its manufacturing
standards into compliance with the Food and Drug Administration's regulations
and to take steps to maintain the required high public health standards in the
future. The commitment is part of a consent decree entered yesterday by
Vintage and its president William S. Propst with FDA and the Department of
Justice in the United States District Court in the Northern District of
Alabama, Northeast Division.
FDA investigators inspected the Vintage facilities in Charlotte, N.C. and
Huntsville, Ala. nine times in the last two years. Although the firm's
regulatory compliance showed some improvement, the inspections found in both
facilities violations of good manufacturing practice including failure to
adequately investigate substandard products, inadequate laboratory controls
and stability testing, and a deficient environmental control system.
FDA sent the firm warning letters and held several meetings with Vintage
management. Vintage responded by promising to remedy the deficiencies, but
most of them were corrected only after FDA initiated an injunction action in
July. Following FDA's inspectional findings, Vintage has also conducted almost
a dozen product recalls in the past year.
Under the terms of the consent decree, Vintage and Propst have agreed to
retain an independent expert who will assist the firm in ensuring that all of
its production processes, facilities and controls are brought up to and remain
in compliance with the public health laws and regulations. The expert will
testify to this effect in periodic reports to FDA.
Vintage Inc., which is based in Huntsville, Ala., manufactures more than
90 generic drugs, including tablets, capsules, and liquids.
Consumer Inquiries: 888-INFO-FDA
SOURCE Food and Drug Administration
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