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