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Quality Assurance

First FDA Inspection: February 1981
Last FDA Inspection: April 2006
Customer Audits each year: over 40

History of last Authorities' Inspections

1998: FDA in ACSD 2
1999: FDA in ACSD 1
2000: FDA in ACSD 2
2002: FDA in ACSD 1 – FDA in ACSD 2 – FDA in ACSD 4
2002: MoH (with EDQM) in ACSD 2
2003: MoH in ACSD 1 - MoH in ACSD 3 - MoH in ACSD 5 - MoH in ACSD 7
2003: FDA in ACSD 1 - FDA in ACSD 2 - FDA in ACSD 5
2004: MoH in ACSD 2 - MoH in ACSD 4 - MoH in ACSD 8
2004: FDA in ACSD 6
2005: FDA in ACSD 1 – FDA in ACSD 2
2006: FDA in ACSD 2 - MoH in ACSD8

U.S. SMARTPAK PATENT

FDA APPROVAL LETTER ACSINFO DATED APRIL 16, 2007

FDA APPROVAL LETTER ACSD1 DATED JANUARY 17, 2006

FDA APPROVAL LETTER ACSD2 DATED JUNE 21, 2006

FDA APPROVAL LETTER ACSD4 DATED AUGUST 23, 2006

FDA APPROVAL LETTER ACSD5 DATED JUNE 2, 2004

FDA APPROVAL LETTER ACSD6 DATED NOVEMBER 30, 2004

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