New Delhi: US health regulator USFDA has issued a warning letter to drug firm Sal Pharma for its Hyderabad facility for misbranding and deviations from the good manufacturing norms.
The US Food and Drug Administration (USFDA) inspected the company’s manufacturing facility at Hyderabad from June 27 to July 1, 2016, the regulator said.
“This warning letter summarises significant deviations from current good manufacturing practise (CGMP) for active pharmaceutical ingredients (API)”, it added.
The letter to Sal Pharma owner Solomon Amrutharajan said: “During our inspection, we found that two of your suppliers were not registered with the FDA as drug manufacturers at the time of inspection.”
However, the company shipped API from these firms to the US, and “declared on importation documents and the certificates of analysis (COA) that you provided to your customers that you were the manufacturer”, it added.
The failure to declare the original manufacturers on the importation documents and COA provided to the customers enabled the entry of unregistered firms’ products into the United States, the warning letter said.
Another deviation was failure to relabel and hold API under appropriate CGMP controls, it said.
Repackaging, relabelling, and holding of API must be performed under appropriate CGMP controls to avoid loss of API identity or purity, the regulator said.
USFDA added that though the company in its response had said that it intended to suspend exports to the US and would address FDA’s observations prior to resuming exports to the country, the response was not inadequate.
“Your response is inadequate because you did not provide sufficient detail or evidence of corrective actions to bring your operations into compliance with CGMP prior to resuming distribution”, it added.
The FDA also strongly recommended to the company to engage a CGMP consultant.
The company also misbranded the itraconazole and lansoprazole API labels as they bear only Sal Pharma’s name without further qualifications, the labels falsely represent that Sal Pharma is the sole drug manufacturer, the letter said.
“Therefore, the itraconazole and lansoprazole API are misbranded under section 502(a) of the FD&C Act because the labels are false and misleading”, it added.
The regulator said it had put Sal Pharma on Import Alert on February 15, 2017.
“Until you correct all deviations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer”, the letter said.
Failure to correct these deviations may also result in FDA continuing to refuse admission of articles manufactured at Sal Pharma in Hyderabad facility into the United States, it added.