Product: pharmaceutical manufacturing facility
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