Regulatory Focus™ > News Articles > FDA Warns Indian API Maker Unimark for Deviations at Two Facilities

FDA Warns Indian API Maker Unimark for Deviations at Two Facilities

Posted 24 August 2016 | By Michael Mezher 

FDA Warns Indian API Maker Unimark for Deviations at Two Facilities

The US Food and Drug Administration (FDA) has issued a warning letter to active pharmaceutical ingredient (API) maker Unimark Remedies Ltd. for poor manufacturing controls and data integrity issues at two of its facilities in India.

During the inspection, FDA officials spotted birds and a lizard at one of the sites, marking the second time FDA has warned Unimark over data integrity issues and the presence of such pests in less than a year.

According to the warning letter, FDA inspected Unimark facilities in Vapi and Bavla, India in May and August 2015. During the inspection, FDA says it uncovered "significant deviations" from current good manufacturing practices (cGMP), leaving the agency to consider products manufactured at the facilities to be adulterated.

In recent years FDA has cited a growing number of Indian drugmakers for data integrity issues, and in April the agency issued a new draft guidance intended to help drugmakers ensure their data is accurate and consistent.

Bavla Facility

In the warning letter, FDA cites Unimark for four deviations at one of its Bavla facilities, including the presence of wild animals in a controlled processing area.

"Among other observations, our investigator found that the walls of your manufacturing area had open holes that could permit ingress of insects, birds, lizards, rodents or other animals to the manufacturing space. During the inspection, the investigator observed dirt and birds in the manufacturing area as well as a lizard," FDA writes.

The finding is strikingly similar to one made in a warning letter to Unimark for another of its Bavla facilities last year in which FDA investigators saw a lizard and bird's nest inside raw materials warehouses at that facility.

In two other citations, FDA says the company tampered with records for both sample testing and employee training.

"Your firm routinely re-tested samples without documented justification and deleted analytical data," FDA writes, adding that the company also failed to investigate the failed results. According to FDA, Unimark blamed the data integrity issues on inadequate training of its employees.

However, FDA says it suspects the company falsified employee GMP training records: "Our investigator 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."

Vapi Facility

During the inspection, FDA says it found multiple instances where Unimark failed to take action on issues that could impact product quality.

First, the agency says Unimark "failed to adequately investigate impurity specification failures" for multiple API batches.

In one instance, FDA says the root cause Unimark listed for a batch failing an impurity test could also have affected multiple batches that had been released after passing impurity testing without investigating the other batches.

Second, FDA says Unimark made multiple changes to its manufacturing process for a specific API without reviewing the changes for potential impacts to quality and did not conduct stability tests of any of the batches produced via the new processes.


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