PAN Drugs receives warning letter from USFDA
USFDA has recently issued a warning letter to PAN drugs Vadodara based plant due to significant deviations from good manufacturing practices.
FDA official said that the firm failed to maintain, repair and keep clean its Active Pharmaceutical Ingredient (API) manufacturing units, with the investigators observing “holes in the walls and roof which allowed pigeons access near production equipment” and gaps and holes in outside walls for piping and air ducts which allow contaminants to enter the building”. The investigator also observed rust, dirt, lubrication leaks and exposed insulation material on and around drug manufacturing equipment. These deviations cause APIs to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act,” USFDA said.
The company also did not indicate if any lot was released without a secondary review of results to ensure compliance with established standards, it added. Until all corrections have been completed and FDA has confirmed corrections of the violations and Pan Drugs compliance with current good manufacturing practice (CGMP), “FDA may withhold approval of any new applications or supplements listing your firm as an API manufacturer,” it added. After receiving Form 483 Pan technical directors Mr. Prem Goel said “We have given the commitment to stop all production while we renovate the facility”.