New Delhi: 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, it added.

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).

The violations at Vapi included failure of the company to adequately investigate and document out-of-specification results and implement appropriate corrective actions, the USFDA said.

“Our investigator found that you failed to adequately investigate impurity specification failures for API batches," it added.

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.

“Our inspection documented that you modified the manufacturing process multiple times for API. Your quality unit did not approve these changes, nor did you document them through a change control review process," it added.

On the Bavla plant, the USFDA said, “Our inspection found that you did not adequately investigate failing or atypical results. Although you obtained failing results in 2014, you did not initiate and document investigations for those failing results until July 2015."

Besides, the company failed to maintain training records of employees involved in the manufacture of intermediates or API, the USFDA said.

“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," it added.

Besides, the investigator 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, the USFDA said.

“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 US health regulator said.

The USFDA issued the letter on 12 August, and has given the company 15 days to respond.

The company could not be reached for comments over the USFDA letter.

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