Locations

Berlin Plant (OH)

  • 213 Employees
  • Total facility size: 233,000 sq. feet (93,000 sq. feet manufacturing space, 10,000 sq. feet office space, 130,000 sq. feet warehouse space)
  • Additional outside warehousing: Public (65,000 sq. feet available)
  • Facility environment: Manufacturing area humidity and temperature controlled

Quality Systems & cGMP

  • Harmonized Quality Systems & Guidelines
  • ISO 9001: 2015
  • Regular internal GMP audits
  • Regular company wide GMP training
  • DMAIC Training  implemented in Berlin

Compliance

  • Programs to Meet Regulatory Requirements
  • Materials Full Traceability & Conformance
  • DMF Maintenance
  • CSA Certification
  • USP 671