Certifications & Licenses

Quality backed by the highest industry standards

iso-9001-certified-logo  Dawn's choice for Video
To provide the highest quality wet wipes, all Nice-Pak/PDI manufacturing facilities are ISO 9001-certified, which means they have achieved and maintained the highest standards of quality assurance.

In addition, the Nice-Pak/PDI Quality System is:

  • GxP-compliant (GLP; GCP; GMP; GAMP as applicable), which ensures world-class validation and compliance for biotech, medical device and pharmaceutical industries
  • UL-certified, which means our products meet and exceed UL’s strict quality accreditation standards

Our Orangeburg, New York, facility is GMP-certified for the manufacture of pharmaceuticals, medical devices and cosmetics. GMP certification ensures that products are consistently produced according to regulations.  Our manufacturing facilities in Mooresville, Indiana, and Jonesboro, Arkansas, have harmonized GMP certifications for consumer products.  Our Mooresville, Indiana, plant was also awarded UL certification for the manufacture of OTC pharmaceutical products.

Licenses:

  • FDA Drug Establishment License 2411192
  • FDA Medical Device License 2411192
  • EPA registration number 9480-NY-001
  • ISO 13485:2003 # FM 88057
  • ISO 9001:2008 # FM 545576
  • Health Canada Site License # 300773