Report: Claris Lifesciences injectables sale may hit roadblock by FDA Form 483

The Business Standard of India reports plans by Claris Lifesciences to sell its generic sterile injectables business may be thwarted by an adverse observation letter the company is reported to have gotten from the FDA. It was recently speculated that Zydus Cadila, another Indian company, was to announce its purchase of the business within the month. However, the Business Standard says the Claris plant was inspected by the U.S. regulatory agency earlier this month and received a Form 483 observation letter that contained 5 observations. The newspaper said Claris couldn't be reached for comment. Article

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