FDA Warns Sun Pharma for Poor Follow-Up with U.S. Recalls

Oct. 14, 2014

The U.S. FDA has warned Sun Pharma's Halol plant in Gujarat for being lax in monitoring the follow-up corrective actions for the drugs it recalled from the U.S. market earlier this year, reports the Economic Times of India.

According to a copy of form 483 issued after last month's FDA inspection and later reviewed by ET, the drugmaker has not put into place a formalized corrective and preventive action plan for the diabetes drug, Metformin extended release,  it recalled from the U.S. market in March. Additionally, Sun has no formal corrective plans for anxiety drug Venlafaxine Hydrochloride extended release tablets, recalled in July.

The FDA also noted several maintenance issues within the plant, as well as an objection to the practice of multiple individuals accessing sensitive production equipment through a common password.

The FDA has followed through with its promise to intensify scrutiny of Indian drugmakers, as the country is the source for more than 40% of the U.S.'s generics and over-the-counter drugs.

Read the Economic Times article