US health regulator has issued a warning to Gujarat-based Pan Drugs over “significant deviations” from good manufacturing norms at its Vadodara plant.
In a letter to the MD and chairman of Pan Drugs, Kamal Pandya, the United States Food and Drug Administration (USFDA) asked the firm to notify within 15 working days of receipt of the letter the specific steps taken to correct and prevent the recurrence of deviations.
“We reviewed your firm’s response dated August 4, 2014. It lacks sufficient corrective actions.”
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,” USFDA said.
While acknowledging that Pan Drugs has informed that it has “decided to divert the referred batches to the domestic (India) market”, the letter said the company had failed to specify whether any lots were released that lacked complete analytical testing information, either because the test was not performed or the data was not recorded.
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.
“In addition, your failure to correct these violations may result in FDA continuing to refuse admission of articles manufactured,” the letter said.
USFDA said its investigator had “identified significant deviations from current good manufacturing practise for the manufacture of active pharmaceutical ingredients” during the inspection of the firms pharmaceutical manufacturing facility at Vadodara during July 14-18, 2014.
“These deviations cause your APIs to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act,” USFDA said.
The FDA investigator during the inspection observed specific violations including the failure to properly maintain, repair, and keep clean buildings used in the manufacture of APIs in a manner that prevents contamination where open equipment is used.
Another violation observed was the failure to properly maintain equipment used in the manufacture of APIs and minimise the risk of contamination, where open equipment is used.
“For example, the investigator observed rust, dirt, lubrication leaks, and exposed insulation material on and around open drug manufacturing equipment,” USFDA said.
“We note that you continued to manufacture product intended for the US market even after you recognised that your facility and equipment were in disrepair and not compliant with CGMP requirements,” it added.
Another failure was to maintain complete data derived from all testing and to ensure conformance with established specifications and standards.