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), calibration of the two front RH and TC (on the left and right inside of the chamber door) with traceability to NIST and NIST certificates. Also requested were all alarm excursions, any (D) unplanned maintenance conducted on the chamber, and the last vendor maintenance conducted back to 01/01/09. On (A) 06/30/10, I was provided a printout of alarms from (E) 08/01/07 to present.  I looked at the RH alarms and there were no alarms from 07/09 to present, only RH excursions from 08/01/07 to 06/10/09. Next QCU said calibrations for the four probes were available for my review. I was provided the four probe calibrations (C&E) with no certificates of calibration traceable to NIST standards. The request was again made on 06/30/10 for review on 07/02/10.
http://www.fda.gov

IF IT’S NOT DOCUMENTED IT’S NOT DONE

A. Timely??????

ASKED Received
06/24/10 06/30/10
06/30/10 2nd Request 07/02/10

B. Copies of associated documents should be included with the qualification package.

C. Equipment file should be kept to hold documentation not in qual packages.

D. Maintenance SOP should include a form to document ALL work done with

E. Using an electronic monitoring system you should have report(s) that pulls data for individual chamber/probes/dates.

ASKED Received
06/24/10 06/30/10
06/30/10 2nd Request 07/02/10

F. Calibration documents used in a PM should be on file with PM/calibration records in compliance to Records Retention Policy (RRP).

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