After receiving a Form-483 from the U.S. FDA earlier this year, Sun Pharma says its Dadra manufacturing facility has now been cleared by the regulator.
During an inspection in April, the FDA found 11 quality lapses at the Dadra unit, which included 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.
Sun Pharma has now received an Establishment Inspection Report (EIR) from the FDA for its Dadra unit, signaling the close of the April inspection.
According to LiveMint reporting, the drug maker’s plant at Halol in Gujarat continues to be under a warning letter from the FDA. Units of Ranbaxy (acquired by Sun in 2015) at Dewas in Madhya Pradesh, Paonta Sahib in Himachal Pradesh and Toansa in Punjab are also under FDA’s import alert.