FDA again slaps Indian API maker Unimark Remedies with warning letter over records, pests

FDA sign

The FDA, which has been on a campaign to get Indian drugmakers to conform with its regulations, slapped Unimark Remedies with another warning letter in which it cited two of the Mumbai-based drugmaker’s plants for keeping poor records, failing to train employees properly, and unsanitary conditions.

Last fall, the company was hit by a warning letter by the regulatory agency at a separate facility  for similar infractions, which included pigeon nests in the building and a lizard roaming in a controlled area.

In the most recent warning letter, during an inspection of the company’s Bavla facility in August 2015, FDA officials “observed dirt and birds in the manufacturing area as well as a lizard in the controlled processing area.” 

There was that at the site as well as a failure to adequately investigate and document out-of-specification results, ensure that test procedures are scientifically sound, and maintain training records for workers involved in the manufacture of intermediates or APIs.

Unimark’s Vapi facility, which was inspected in May 2015, was cited for failing to follow-up on out-of-specification results or evaluate the potential effect that changes in the manufacturing process may have on the quality of its APIs.

Poor-record keeping and unsanitary conditions have become a common theme of FDA warning letters to Indian drugmakers. The U.S. agency and regulators in Europe have dialed up their inspections in recent months and years, resulting in punishments for companies such as Wockhardt, Sun Pharma, Ranbaxy Labs and others.

According to a survey by Reuters last year, more than 40 drug production facilities in India have been banned by the FDA.

- check out the FDA warning letter

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