- MedPharm has successfully completed a U.S. FDA inspection of its commercial topical drug manufacturing facility in Durham, North Carolina.
- The inspection concluded with no Form 483 issued and a No Action Indicated (NAI) classification.
MedPharm has announced the successful completion of a U.S. Food and Drug Administration inspection at its topical drug product manufacturing facility in Durham, North Carolina. The inspection supports the site’s commercial manufacture of drug products.
The FDA inspection resulted in no Form 483 observations and an NAI classification, according to the company. MedPharm stated that the outcome reflects the strength of its quality systems and operational processes at the site, which supports both clinical and commercial activities.
The Durham facility is a purpose-built, 110,000-square-foot site that houses research, development and analytical laboratories, alongside quality assurance systems and CGMP manufacturing capabilities for semi-solid dosage forms. The site recently added ICH-compliant stability storage capabilities, and multiple products have already been filed from the facility.
“Receiving an FDA inspection outcome with no Form 483 issued and NAI classification is a powerful testament to the rigor of our Quality Systems and the discipline of our teams.”
Bill Humphries, Chief Executive Officer of MedPharm
MedPharm operates as a contract manufacturing and development organisation (CDMO) specialising in topical and transdermal drug products. The company said it continues to expand its manufacturing footprint while supporting clients through drug development and commercial supply.
