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Tech Group Rockford has Successful FDA Inspection

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Tech Group Rockford recently completed its third PAI (Pre-Approval Inspection) associated with a customer’s New Drug Application (NDA) filing with the FDA. The purpose of a PAI is to ensure that the facility is in compliance with FDA rules and regulations for the contract manufacturing of a customer’s medical device. 
 
“A successful PAI is certainly a positive step toward obtaining FDA approval to produce our customer’s device,” said Mark McElfresh, Plant Manager at Tech Group’s Rockford facility.  “Successful PAI sets the Tech Group apart from other contract manufacturers, and definitely proves that we are doing all we can to ensure efficient, controlled production that meets or exceeds set regulatory requirements.”
 
Leigh Toole, Quality Director at the Rockford facility, said that “during the three-day inspection, the FDA investigator reviewed our Quality Management System for compliance to current Good Manufacturing Practices (21 CFR Part 820). The inspection also focused on manufacturing readiness for this new product that requires pre-market approval from the FDA.” 

Tech Group completed the intense inspection without receiving a 483 letter, which documents inspection deficiencies in quality system (manufacturing operations, materials, facilities and/or equipment) from the FDA.
 
“We have a very good team in place,” noted McElfresh.  “And we’re pleased and proud that Tech Group has once again proved itself a high-quality manufacturer.”

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