US FDA warns Indian API maker for faking certificates of analysis
The letter dated April 20 was sent following an inspection by the US Food and Drug Administration (FDA) last June and July at the active pharmaceutical ingredient (API) maker’s Hyderabad, Andhra Pradesh facility.
Amid the deviations from current good manufacturing practice (cGMP), the Agency found Sal Pharma had failed to transfer quality and regulatory information received from its own API manufacturer to its customers.
“You omitted the names and addresses of the original manufacturers of your API on certificates of analysis (COA) you issued to your customers. You generated your COA by replacing the original manufacturers’ information with your letterhead.”
The Agency added two of Sal’s suppliers were not registered with the FDA at the time of inspection, yet the firm shipped API shipped from these suppliers to the US declaring itself to be the manufacturer.
“Customers and regulators rely on COA for information about the quality and source of drugs and their components. Omitting information from COA compromises supply-chain accountability and traceability, and may put consumers at risk.”
Sal Pharma was also pulled up on API repackaging and relabeling issues. Furthermore, the company was unable to “confirm whether or not [its] clearing agent securely stores API in a temperature-controlled environment.”
According to the letter, the facility makes itraconazole and lansoprazole API for export to the US, but the FDA also accused the firm of misbranding violations.
“The itraconazole and lansoprazole API labels identify Sal Pharma but do not designate the firm’s role. Since these API labels bear only Sal Pharma’s name without further qualifications, the labels falsely represent that Sal Pharma is the sole drug manufacturer.”
The firm now has 15 days to respond to the FDA and present a remediation plan for the facility which has been on import alert since February.
