warning letter

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Analysis of the Claris Warning Letter

The Warning Letter to Claris Lifesciences was one that went on and on, page after page citing violations of fundamental, block-and-tackling practices. This was surprising and a disappointment given that Claris is one of the largest sterile injectable pharmaceutical companies in India with a market presence in 76 countries worldwide.  From a patient’s perspective, their products are injected directly into [...]