Pan Drugs Limited Hit With FDA Warning Letter
Indian active pharmaceutical ingredient maker Pan Drugs Limited was hit with an FDA warning letter after an inspection revealed data integrity issues and significant cGMP violations, leading the company to announce it would sell its product locally. The company will stay on the FDA’s Import Alert list until it makes the corrections.
The FDA noted that the firm continued to manufacture APIs for the U.S. market even though the facility was not cGMP compliant, to which Pan Drugs responded “we have decided to divert the referred batches” to the Indian market.
Pan Drugs also told the FDA inspector during the July 14 to 18, 2014, inspection of the Gujarat, India, site that it produced only one API for the U.S. market. But after reviewing import entries, the FDA found it manufactured and shipped significant quantities of other APIs to the U.S.
GMP violations included failure to maintain, repair and keep clean buildings to prevent contamination, as well as failure to properly maintain equipment used in manufacturing APIs. The inspection revealed holes in the walls and roof, and the inspector observed rust, dirt, lubrication leaks and exposed insulation material on and around equipment.
Investigators also found that the firm failed to maintain complete data from all testing and to ensure conformance with specifications and standards. For one lot, a heavy metal analysis was not performed, the name of the analyst who performed the test was not included and no second follow-up review of the results was completed, the warning letter said.
In response, the firm said that it would take corrective actions for such oversight errors, but did not specify if any released lots lacked complete analytical testing information or a secondary review.
The warning letter is the latest in a slew of warnings and Form 483s issued to Indian and foreign API makers related to cGMPs and data integrity issues.
Until the corrections have been made and the FDA has confirmed them, the agency said it may withhold approval of any NDA or sNDA that lists Pan Drugs as an API manufacturer and refuse admission into the U.S. of any of the company’s products.
Pan Drugs did not respond to a request for comment by press time. The warning letter is available at www.fdanews.com/09-16-15-PanDrugs.pdf. — Kellen Owings