Sun Pharma Halol Plant Review Resulted in 14-Page FDA Report

Updated on
  • Stock drops in Mumbai trading after FDA says Form 483 produced
  • Halol plant has been under warning letter since last December

A U.S. Food & Drug Administration inspection of Sun Pharmaceutical Industries Ltd.’s facility in Halol, India, has given rise to a 14-page inspection report that could list potential violations of the agency’s manufacturing guidelines.

The report, called a Form 483, is currently under review and will be available by the end of the week, the FDA said in a response to a Freedom of Information request submitted by Bloomberg News. Sun Pharma in a regulatory filing said it would respond to the letter within 15 days. Its shares dropped as much as 6 percent in Mumbai trading. 

The regulator didn’t give details or any indication of the seriousness of the observations. The FDA’s website says that a Form 483 is issued to a company when inspectors note any conditions that may constitute violations of the Food Drug and Cosmetic Act. The agency also says that the report does not constitute a final decision of whether any regulations were violated.

"There will be many things, that’s why you’ve taken 14 pages, so that gives a negative connotation," said Daljeet Singh Kohli, head of research at India Nivesh Securities, in a phone interview from Mumbai. "We don’t know if it will all be negative, but what it simply means is there are many portions you will need to talk about, that’s why you would need so much space."

The FDA considers company responses and other documents before deciding what further action, if any, is appropriate after a Form 483.

Sun’s Halol plant received a warning letter last year from the regulator due to past violations which has prevented new product launches from the facility in the U.S., Sun’s largest market. That has slowed revenue growth at India’s largest drug maker and imposed new costs to bring the plant back up to standard. The latest U.S. FDA inspection came after Sun invited the agency back to review a year’s worth of remediation efforts in the hopes the warning letter would be lifted.

"The stock performance actually hinges on Halol," Kohli said. "A lot of filings are done from there, and future prospects are dependent."

Frederick Castro, a spokesman for Sun, declined to comment on the length of the U.S. FDA’s Form 483 observation letter. The 483 report arose from an FDA inspection of its Halol facility that ended Dec. 1, the company’s filing said.

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