Magazine article Drug Topics

FDA Safety Inspections of Foreign Rx Plants Lacking, GAO Charges

Magazine article Drug Topics

FDA Safety Inspections of Foreign Rx Plants Lacking, GAO Charges

Article excerpt

Most foreign pharmaceutical manufacturers and bulk chemical suppliers to the U.S. drug industry will never undergo an FDA inspection to guarantee quality and safety, according to a GAO report. Reports on the inspections that are conducted are submitted late, and these include "half the reports that identified the most serious deficiencies in manufacturing quality." In addition, twothirds of the field investigator's enforcement recommendations were downgraded by superiors at headquarters, based on promised remedial action by the inspected firm. In one inspection in India, an FDA chemist characterized a bulk drug supplier's tests for measuring impurities as "incompetence bordering on fraud." Instead of a ban, as the inspector urged, headquarters accepted the manufacturer's response without requiring a reinspection.

Another inspection in India in 1994 found that quality deficiencies identified in 1985 had not been fully corrected. In this case, headquarters agreed to ban the maker's products and take other enforcement actions, but "lost track of [the paperwork] during staffing changes," GAO said. It took two years for the FDA to discover the oversight during which time the imports continued.

As recently as last year, the FDA lacked a complete list of foreign manufacturers shipping pharmaceutical products to the United States. …

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