Mylan.
Product: pharmaceutical manufacturing facility
Date: 8/6/2015

Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel can change master production and control records, or other records (21 CFR 211.68(b)).

Your Siemens computer-based BMS and NVPMS do not require passwords to access the network and servers. Your contractors? access is uncontrolled. Responsibilities for system administrators are undefined.

This violation is recurrent. On September 9, 2013, we cited your firm in Warning Letter 320-13-26 for failure to exercise appropriate controls over computer or related systems

FDA District Office: CDRH

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
Registration Link

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.