The FDA cited a Glenmark Pharmaceuticals facility in Solan, India for failing to investigate discrepancies, inadequate complaint records and improper maintenance of quality data.
The agency issued a Form 483 following a November inspection of the facility. Investigators found the facility did not properly review out-of-specification results, instead invalidating them through retesting and reporting the results that passed. The inspection found no written procedures for ensuring drug products had the proper identity, quality, strength and purity.
The FDA also faulted Glenmark for its complaint handling. Glenmark received more than 30 consumer complaints on a batch released to the U.S. market in April, representing about half of all complaints for the product received this year, but the investigation into the complaint failed to determine whether the longer bulk hold time for the batch in question impacted the product.