Pharma Tech Industries Completes FDA Pre-Approval Inspection for Manufacture of a New Prescription Drug
PAI (Pre-Approval Inspection) is concluded with no “483 Observations”
Royston, GA: Contract manufacturer Pharma Tech Industries (PTI) has just successfully completed both a General Inspection and a Pre-Approval Inspection (PAI) by the FDA for its readiness to manufacture and package a new prescription drug formulation.
“After a four-day inspection by the FDA, PTI emerged with receipt of no 483 observations. In fact, in our over fifteen year history, PTI has never receieved a 483 observation by the FDA, which is a testament to our relentless focus on quality,” notes Carl Oberg, PTI President.
PTI is supporting the client’s NDA filing registration with product test batches and documentation supplied from in-house R&D, manufacturing and QA.
The Royston, GA facility of PTI will be the sole manufacturing site for the drug.
Pharma Tech Industries, Inc., is a family and key-employee owned pharmaceutical contract manufacturer and packager that provides strategic outsource services for product development, technology transfer, and turnkey manufacturing of pharmaceuticals and personal care products.
A workforce of 300 operates from convenient, strategic locations in Union, MO and Royston, GA to offer high quality, closer-to-home contract outsourcing services. A dedicated project management team, a knowledgeable and experienced domestic workforce and strong cGMP systems enable customers to exceed quality and service objectives with cost saving efficiencies.
For more information, please contact Mr. Tee Noland; Pharma Tech Industries; 545 Old Elbert Road; Royston, GA 30662; Tel: (706) 246-3527; email: sales@pharma-tech.com.