Why USFDA issued warning letter to Unimark Remedies?

The US Food and Drug Administration (USFDA) has warned Mumbai-based Unimark Remedies Ltd for violating good manufacturing practices at its two plants in Gujarat. Failure to correct these deviations may also result in the USFDA refusing admission of articles manufactured at Vapi and Bavla facilities into the US.

In a warning letter, the USFDA said inspectors from 18-22 May 2015 had found significant deviations from standard manufacturing practices at the company’s plants in Ahmedabad, which manufacture active pharmaceutical ingredients (API).

Few Points regarding the USFDA inspections as follows –

• The violations at Vapi included failure of the company to adequately investigate and document out-of-specification results and implement appropriate corrective actions.
• USFDA investigators found that unimark failed to adequately investigate impurity specification failures for API batches.
• Further, the company failed to evaluate the potential effect that changes in the manufacturing process may have on the quality of its API, the USFDA noted.
• On the Bavla plant inspection found that company did not adequately investigate failing or atypical results.
• Besides, the company failed to maintain training records of employees involved in the manufacture of intermediates or API, the USFDA said. USFDA found that your employees’ CGMP training records contained numerous discrepancies that raise doubts regarding their authenticity. For example, the inspection documented that 10 of 11 training records contained identical handwritten responses.
• Besides, USFDA investigators found that the walls of the manufacturing area had open holes that could permit ingress of insects, birds, lizards, rodents or other animals to the manufacturing space.