Articles & Editorials Articles & Editorials from mdiConsultants, Inc. What is needed for FDA QSR compliance as a Specification Developer a warning letter was recently issued to a company (dated Sept 11, 2012) that was registered as a “specification developer”. Foreign Companies Beware –The FDA is on the WARPATH FDA compliance has been much more difficult to deal with. No Silver Bullet to Complying with the US FDA GMP's Article for the Chinese agency, CCUS (Certification Center International Standards) CHINESE VERSION ENGLISH VERSION Published in the Chinese Pharmaceutical Technology Exchange, Vol. 7 No.1 2007: Reprinted by permission Japan to require ISO13485 What You Need to Know About Contract Manufacturing An article by Alan Schwartz, appearing in the July/August 2006 issue. Outsourcing - Control is the Key to Success An article by Alan Schwartz and George Ye **This Magazine article is in Acrobat PDF format. HACCP Inspectional Approach for Medical Device Manufacturers "Should Industry be Accepting?" by Alan P. Schwartz GMP vs. ISO Considerations in Achieving ISO Certification By Alan P. Schwartz REVISED GMPs A call for real added value By Alan P. Schwartz Published in Medical Industry Executive February/March 1994