USFDA issues warning letter to Unimark Remedies

US Food and Drug Administration (USFDA) has issued a warning letter to Mumbai-based Unimark Remedies for violating current good manufacturing practice norms at its plant near Ahmedabad in Gujarat. In a warning letter, USFDA said an inspector in March had found significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients at the plant. The significant violations included failure of the company to document production and analytical testing activities at the time they are performed, the USFDA said.

The company failed to prevent unauthorised access or changes to data and to provide adequate controls to prevent omission of data, it added. "Your laboratory systems lacked access controls to prevent raw data from being deleted or altered," the US health regulator noted. The drug firm also failed to maintain complete data derived from all testing, it said.

"Your quality system does not adequately ensure the accuracy and integrity of data generated at your facility to support the safety, effectiveness, and quality of the drug products you manufacture," USFDA said. The company could not be reached immediately for comments over the FDA letter. Unimark has presence across various therapeutic segments such as respiratory, cardiovascular, anti-infectives and central nervous system.