Related FDA483/Warning Letter The written stability program for drug products does not describe the storage conditions for samples retained for testing. Specifically: Sub section (b)There is no written standard operating procedure in place to (A) control, secure, and allow authorized personnel to access the stability chambers. It appears that...
Articles from May 2016
FDA 483 Tips #4
Procedures describing the calibration of instruments and apparatus are deficiently written or followed. Related FDA483/Warning Letter b) The two calibration points evaluated were 0 C and 100 C, thus there was no challenge to the actual range of operation which were mentioned to be C to C....
FDA 483 Tips #3
Procedures describing the calibration of instruments and apparatus are deficiently written or followed. Related FDA483/Warning Letter d) The (A) calibration program for your stability chambers is deficient in that it does not include specific directions and schedules. You do not (B) perform re-qualification of the stability chambers. The original...
FDA 483 Tips #2
Records associated with drug product production and control and within the retention period for such records, were not made readily available for authorized inspection Related FDA483/Warning Letter Sub section M. On 06/24/10 a request was made for the last performance qualification for the (B) Walk-In Stability Chamber (25/60),...
FDA 483 Tips #1
Routine inspection of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance. Related FDA483/Warning Letter Subsection D. (A&B) No written procedure is approved by QA describing Preventative Maintenance tasks and their frequency for concerning monthly tasks for the walk-in RH...