STAMULLEN, 11 May 2015. Millmount Healthcare, the award-winning Irish owned organisation specialising in blister and bottle/tub contract packaging, announces today it has recently been audited and approved by the U.S. Food and Drug Administration (FDA).
Two inspectors from the FDA were scheduled to perform a PAI and general GMP inspection from April 20th to 25th on our CityNorth site. Due to the auditors’ confidence in Millmount Healthcare, this was reduced to 3 days. Both auditors were highly experienced and one in particular has completed over 400 foreign inspections in her career as auditor. They were very impressed with our facility and the calibre of people they interacted with and remarked that the Millmount Healthcare Quality Systems were in line with their expectations from Big Pharma. We received no citations during the course of the audit.
“This very successful audit is a big step in Millmount’s journey as we have now proven we can package product and have the quality systems in place which are acceptable for US standards,” Pascal Keogh, Managing Director, said. “With this accomplishment we can now actively market US companies for additional business. In addition to our HPRA, GMP, Veterinary and IMP licences, this proves to be a very welcome extension to our portfolio and means we will now be in a better position to serve the market with a diversification of service offerings.”
David Geraghty, Millmount Healthcare’s Head of Quality also comments, “The success of this audit proves that the Process and Quality Systems in place at Millmount Healthcare meet the required standards and are robust as the company grows.”