Sun Pharma has had another setback in its manufacturing for the U.S. market with the FDA laying out nearly a dozen observations for a solid dose formulation plant in Dadra.
India’s largest drugmaker said in a filing this weekend that the FDA had issued the 11 observations following an inspection that ended April 13. Opened in 2002, the 120,000-square-foot plant was designed to produce tablets and capsules.
Sun provided no details about the observations, but Bloomberg, which has obtained a copy of the FDA document, reported it includes concerns over data integrity issues, as well as criticism for not getting to the root cause of failed batches. Inspectors also noted that the plant’s quality-control unit didn’t have the authority to review manufacturing records.
In its filing with the Bombay Stock Exchange Saturday, Sun pointed that “Sun Pharma and its subsidiaries have many facilities which supply products to the U.S. market" that undergo periodic inspection by the FDA.
One of Sun Pharma’s plants that has seen a lot of the FDA is its key formulation plant in Halol, a facility for which regulatory concerns have created supply issues for Sun in the U.S. market. That plant first received a Form 483 in 2014, which was bumped up to a warning letter the next year. Sun brought in consultants and has invested in new systems at its Halol plant, but it so far has not been enough to satisfy the agency. Late last year, the FDA was back for a reinspection and left another Form 483 for Halol.