We are pleased to announce that in the FDA’s most recent inspection of our St. Louis, MO facility (November 2009), there was not a single 483 issued. Our Edison, NJ facility was inspected in February 2009 and did not receive any 483s either. Tap into our expertise in CGMP compliance and FDA expectations: we can help. The Celsis quality assurance programs focus on constant scrutiny, feedback and assistance to our analytical operations. This common goal between departments ensures the highest degree of accuracy and integrity for our test results and regulatory compliance. Quality System Certification and Registrations Memberships The processes that support our quality commitments are detailed in our Standard Operating Procedures (SOPs), which are based on current guidelines of the International Standards Organization (ISO), the U.S. Code of Federal Regulations and proven principles and practices.
Harmonization USP Changes |
