The FDA issued a warning to a Belleville, N.J. OTC drugmaker US Pharmaceuticals for serious failures in its purified water system including high microbial counts.
The investigators found that the facility did not fully investigate failing microbiological and chemical test results. Specifically, it did not look into multiple results for certain purified water lots that were above the total aerobic microbial count limit.
The agency also noted 10 different incidents of chemical testing failures that were not investigated. Some water samples exceeded total organic carbon content limits in several water lots used to manufacture drugs.