New Delhi: Data integrity issues, including failure to prevent unauthorised access to laboratory records, are among issues cited by the USFDA in its warning letter to Divi’s Laboratories for Visakhapatnam facility.
The United States Food and Drug Administration (USFDA) has issued the warning letter to the domestic drug maker for non-compliance of good manufacturing norms at Unit II of its Visakhapatnam facility.
The unit produces active pharmaceutical ingredients (APIs), raw materials used for producing medicines.
“Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” the USFDA said in its letter to company director and president of operations Kiran S Divi.
The letter, which was issued after USFDA investigators inspected the company’s Unit II at Visakhapatnam from November 29 to December 6, 2016, said there was “failure to prevent unauthorised access or changes to data and failure to provide adequate controls to prevent manipulation and omission of data”.
It further said methods, facilities, or controls for manufacturing, processing, packing or holding at the facility did not conform to CGMP and therefore the “APIs are adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act”.
There was “failure to ensure that test procedures are scientifically sound and appropriate to ensure that your (company’s) API conform to established standards of quality and/or purity”, the letter said.
The USFDA also said the company gave only limited access to its investigators, which also counted as violation of norms.
While acknowledging that it had reviewed responses of the company in detail, the USFDA asked Divi’s Labs to provide a comprehensive investigation into the extent of inaccuracies in data records and reporting.
The regulator also asked for a current risk assessment of the potential effects of the observed failures on the quality of drugs.
“Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity, and risks posed by ongoing operations,” the letter said.
The regulator asked Divi’s Labs to provide a management strategy for the firm that includes the details of its global corrective action and preventive action plan.
“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 the Unit II at Visakhapatnam into the US, it said.