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Dalton Pharma Services Completes PAI Inspection

Paves way for Dalton to manufacture commercial API products for U.S. distribution

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By: Kristin Brooks

Managing Editor, Contract Pharma

The U.S. FDA completed a PAI inspection of Dalton Pharma Services’ Health-Canada licensed manufacturing facility in Canada, in January 2019. This inspection paves way for Dalton to manufacture commercial API products for U.S. distribution. The entire facility and the quality systems used for the manufacture and release of APIs were subject to a detailed compliance inspection by the FDA.  No FDA 483 inspectional observations were issued. This inspection means that the company has successfully ...

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