RAPS: FDA Warns Sun’s India Plant Over Sterility Concerns

Serious aseptic and sterility violations, including water damage and leaks in parenteral manufacturing areas, were documented by the US Food and Drug Administration (FDA) in the latest warning letter for Sun Pharmaceutical’s manufacturing plant in Halol, India. Since the September 2014 inspection, FDA has withheld future product approvals from the Halol facility. The company was cited in a separate warning letter in May 2014 for data integrity concerns (trash bags of good manufacturing practice records were found) at its manufacturing site in Gujarat, India, which is also included on FDA’s import alert list.