The U.S. FDA noted 11 observations during an inspection of Sun Pharmaceutical Industries' Dadra facility this month, according to an inspection report obtained by Bloomberg News.
In the Form 483, the FDA noted incomplete laboratory records, failure to create accurate duplicates of key records, failure to properly investigate drug batches that didn’t meet specifications, as well as some additional quality control issues.
In March, Sun announced the FDA had lifted its import ban against a facility in Punjab. In terms of the Dadra facility, Sun Pharma said they are currently in the process of responding to the FDA letter within the stipulated timeline of 15 days.
Read the Bloomberg coverage
