Sun Pharma Plant in India Hit with FDA 483

Sun Pharma Plant in India Hit with FDA 483

September 17th, 2018 // 6:51 pm @

FDA inspectors in early September 2018 spotted several GMP issues at Sun Pharm’s manufacturing facility in Halol, Gujarat, India. This OAI inspection result put the drug manufacturing facility back in the spotlight after it got the green light from FDA in 2017. The pre-approval inspection noted six GMP related problems, including issues with the plant’s testing procedures for pharmaceutical products.

The FDA inspection report came only six months after FDA resolved several regulatory issues for Sun Pharma and the plant in India. In 2015, FDA gave the company an FDA warning letter, which held up new approvals for drugs that were made at the site.

Getting clear of the issues noted in that warning letter has taken several years for Sun. This reduced its ability to boost market share in the United States.

But in June 2018, FDA released an Establishment Indication Report that stated the company’s plant was in the Voluntary Action Indicated category. This suggested that some issues were still outstanding, but did not require regulatory action. Now that Halol is being cited by FDA again is not a good sign, even if it turns out that the issues are relatively minor.

The FDA 483 noted several problems, most of them related to drug stability testing written procedures. Also, tests were not done on raw materials for Burkholderia cepacia on several drug samples. In a capsule filling process, FDA auditors noted that the equipment at the plant was not functioning as it should. This required the staff to make manual interventions.

It is unclear if the FDA 483 observations will trigger increased regulatory action. One drug analyst does not think there will be a major impact. According to Praful Bohra, there should not be a serious holdup of approvals for the drug facility. The current plant status is good, and it can keep exporting and get new FDA approvals.

Sun has noted on its website that it will respond to FDA within the required 15 days. Sun recently also did a product recall on a single lot of metformin hydrocholoride tablets; this was because a piece of a rubber glove was found in a drug tablet. That lot was made in Halol.


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