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The US Food and Drug Administration (USFDA) has warned Unimark Remedies on violation of good manufacturing practices at its two plants in Gujarat.
It added that failure to correct these deviations may also result in FDA refusing admission of articles manufactured at Vapi and Bavla facilities into the United States.
The USFDA, in a warning letter said that the inspectors from May 18 to 22, 2015 had found significant deviations from standard manufacturing practices at the company’s plants in Ahmedabad district of Gujarat that manufactures active pharmaceutical ingredients (API).
