Dalton Pharma Services Successfully Completes Its First FDA Pre-Approval Inspection of Its Canadian Manufacturing Facility
TORONTO May 02, 2019 - Dalton Pharma Services announced that the US Food and Drug Administration (FDA) completed a PAI inspection of its Health-Canada licensed manufacturing facility in Canada, in January 2019. This inspection paves way for Dalton to manufacture commercial API products for US distribution.
The entire facility and the quality systems used for the manufacture and release of APIs were subject to a detailed compliance inspection by US FDA. No FDA 483 inspectional observations were issued. This inspection means that the company has successfully demonstrated these activities are in compliance with the high standards of the Food and Drugs Act and its associated regulations.
Natalie Lazarowych, Director of Quality, stated, “This successful inspection is a critical breakthrough for Dalton as it is the first ever PAI at our facility. The successful FDA inspection with no 483s demonstrates our commitment to meeting all applicable regulatory standards for commercial manufacture, packaging and testing.”
“I am proud of my team and their efforts in accomplishing this organizational milestone. Our hardworking, dedicated and exceptional employees are our greatest asset. This successful inspection exemplifies Dalton’s commitment to being a compliant cGMP API manufacturer for all our client`s drug candidates.”, said Peter Pekos, CEO.
About Dalton Pharma Services:
Dalton Pharma Services is a leading North American cGMP pharmaceutical organization providing integrated drug discovery, development and manufacturing services. Our strong regulatory history, Health Canada establishment license, successful FDA PAI and 30+ years of experience allow us to effectively deliver fully integrated solutions with an emphasis on speed, flexibility and quality. Our integrated services (drug discovery, formulation and process development, custom synthesis, cGMP sterile fill/finish of liquids and powders, cGMP API manufacturing and/or dosage form manufacturing and Accelerated Stability Testing) all at one location helps us to be adaptable, flexible and cost-effective.
To learn more about our history and capabilities, please visit https://www.dalton.com.
Peter Pekos
CEO
Dalton Pharma Services
349 Wildcat Road
Toronto, Ontario
Tel: 416-661-2102