The FDA found that Sun Pharma, which produces generic drugs for U.S. consumers, failed to investigate the source of bacteria found in test vials or promptly deal with damaged equipment that had caused drugs to be contaminated with metal particles.

FDA Inspectors Again Find Dangerous Breakdowns at an Indian Factory Supplying Medications to U.S. Consumers
The latest inspection comes 2 1/2 years after the agency allowed Sun Pharma to keep shipping some drugs to Americans even after banning the factory from the U.S. market because of quality problems.