The U.S. FDA has issued a warning to Gujarat-based Pan Drugs over "significant deviations" from good manufacturing norms at its Vadodara plant.
The FDA inspected the plant in July 2014 and has stated that Pan's response the following month lacked sufficient corrective actions.
Last year's inspection revealed several violations, including holes in the walls and roof that allowed pigeons access near production equipment, and rust, dirt and insulation on and around manufacturing equipment. Additionally, the FDA found a disparity between the statement made by Pan regarding how many APIs were distributed to the U.S. market and the importation records for drugs shipped to the United States.
According to the FDA letter, "until we receive adequate confirmation that you have made global corrections, we will not schedule a follow-up FDA inspection and your firm will remain on Import Alert 66-40."
Pan Drugs manufacturers Acetaminophen pain reliever, Guaifenesin expectorant, and Methocarbamol muscle relaxant, according to the company's website.
Read the FDA letter
