warning letter

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17 12, 2010

Analysis of the Claris Warning Letter

By | 2017-11-06T01:20:01+00:00 December 17th, 2010|Biopharma / Pharma, cGMP Quality Assurance and FDA 483s, FDA, FDA Inspections, Form FDA 483|

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 [...]