Wednesday, May 4, 2016

Warning Letter of the Week: Lost safety glasses edition

Looks like Polydrug Laboratories got a tough 483 from the FDA recently:
Our investigator observed specific deviations during the inspection, including, but not limited to, the following.

1.    Failure to record and investigate all quality-related customer complaints according to an established procedure.

During the inspection our investigator found a torn sheet of paper titled “Product Quality Complaints” on the floor of your warehouse. We compared it to your firm’sofficial complaint log and discovered that only 2 of the 17 customer complaints on the torn sheet were recorded in your firm’s official complaint log. Further, your firm indicated that there may be additional unlogged and/or uninvestigated complaints, but did not provide further explanation. Your firm had not investigated the complaints we found on the torn sheet. These uninvestigated complaints reported API that were either sub-potent or contained filth, including the following problems:
  • low assay value for [redacted] API
  • particles and hairs in [redacted] API
  • an insect and dirt in [redacted] API
  • safety goggles in [redacted] API
  • [redacted] scoop in [redacted] API
I'm a little surprised about the lost safety goggles and scoop - I am under the impression (that like surgical suites and the dreaded sponge count) items need to be logged in and out of final product packaging areas. 


  1. I can't say I have ever seen actual log in/out procedures in dealing with APIs so where did you get such an impression? Most batch records will comprehensively list out the items to be used, either product dedicated or disposable so unless there is a cleaning record no real post-use reconciliation is done beyond standard pre- and post- room clearances. Something like safety googles are unlikely to be covered anyway since typically fall under general or the specific product PPE and room requirements. Drug Product manufacturing is more controlled and strict but again never seen tracking of every single utensil and PPEs as an extreme. The list above speaks more directly to poorly trained or inattentive operators which in the end may reflect a bigger systematic GMP violation than the particular reports (which is reinforced by the torn paper incident)

    1. Not in API, but I have seen post-room clearances for pens and the like. I would think a scoop would fall under that? (Maybe not.)


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