and the seriousness of the violations uncovered during our
inspections of these two sites. The firm is
sufficiently out of control that we think an import alert should
be put into place until these deficiencies are corrected."
Deborah Autor, Director of the Food and Drug Administration's Drug Compliance Office
Earlier this year, the Justice Department asked a U.S. District
Court judge in Maryland to force Ranbaxy to turn over audits
completed by a contractor, which the company later agreed to
provide. The Government is
investigating allegations including conspiracy, false statements
and health-care fraud.
In the July court motion, the Justice Department claimed that "allegations from reliable sources and supporting
documents indicate a pattern of systemic fraudulent conduct,
including submissions by Ranbaxy to the FDA that contain false
and fabricated information.''
Ranbaxy has denied the
allegations, and no charges have been filed.
The FDA issued a warning to Ranbaxy after a February 2006
inspection of the plant in Paonta Sahib that found 'significant
violations'. The FDA inspected that plant again, along with the
plant in Dewas, earlier this year, resulting in the warning letters
issued yesterday, according to the agency's statement after the FDA
concluded that Ranbaxy's response to its inspections was
inadequate. Products will be blocked until Ranbaxy resolves
deficiencies at the plants, according to the FDA.
It's an interesting situation overall. Public awareness of quality and safety issues are at a high after the Heparin storm with Chinese suppliers using synthetic replacements in the raw ingredients and pets dying from contaminated pet food.
After all, it is not unreasonable that products entering the US market should be proven to meet the required standards for safety and efficacy. The public have a right to be reassured that the products are indeed what they are expected to be. The heparin incident taught everyone that vigilance is vital to quality and safety of drugs.