December 10, 2009
Colorado Springs-based Provident Pharmaceuticals LLC has received a warning letter from the U.S. Food and Drug Administration alleging significant violations of federal regulations on drug manufacturing as well as sales of unapproved drugs.
The Nov. 9 letter resulted from a June 1-19 inspection of Provident’s plant at 4831 Centennial Blvd. and ordered the company to stop production and distribution of the unapproved drugs, which it said “are not generally recognized as safe and effective for their labeled uses.” The agency removed all references to what unapproved drugs Provident is alleged to be making and selling in a copy of the letter posted on its Web site, www.fda.gov.
The agency also raised concerns about Provident’s “commitment to ensure compliance with” its current “good manufacturing practice” regulations and recommended the company hire a qualified consultant to provide comprehensive training on its manufacturing regulations. The letter also recommends that the company revise its internal audit program and procedures related to good manufacturing practice to identify and correct any departures from those practices.
Company officials did not respond Thursday to a phone call seeking comment.
The FDA’s inspection found that Provident “failed to establish valid test methods for raw materials and drug products” to make sure they meet the agency’s standards and also failed to ensure some samples were tested when they were scheduled to be, the letter said. The company approved test methods that failed to meet the agency’s criteria and it validated a method that “is not intended for the testing of (redacted) product,” according to the letter.
The agency also said the company failed to make sure that tests that showed drugs it manufactured did not meet specifications were thoroughly investigated and said it had concerns about Provident’s “fundamental understanding of the regulatory expectations and requirements” of such investigations. The letter also said the company didn’t conduct annual product reviews as required or conduct an internal audit to verify it corrected the problems identified in the inspection.
The FDA also called several of Provident’s responses to allegations in the warning letter inadequate and indicated that “failure to have an adequate number of qualified personnel is not justification to circumvent” the agency’s regulations.
Provident was started in 2003 in Colorado Springs as a contract manufacturer of prescription cough and cold drugs and had grown to 70 employees by 2007, the latest date for which information is available. Provident was cited in 2007 by the U.S. Occupational Safety and Health Administration for allegedly exposing its workers to unsafe levels of a drug used to treat ulcers and faces fines of up to $251,500 in a trial before an administrative law judge that is scheduled to begin March 22.
Contact the writer at 636-0234