FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Colorado Drugmaker Taken to Task for Repeat Violations

July 11, 2019
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Maple Rose Enterprises drew a lengthy Form 483 for a long list of transgressions at its Denver, Colorado facility, including shoddy conditions, equipment calibration failures and actions that risked contamination.

The agency’s investigators logged 11 observations during their Feb. 11-26 inspection, of the  sterile and non-sterile drug manufacturing facility, some of which were repeat violations from a previous inspection.

Buildings used for drug processing were in a similar state of disrepair as seen in an August 2016 inspection. The investigators noted a dent in the wall across from an ISO 5 biosafety cabinet workspace, seemingly unfunctional HEPA filters in the ante room, unclean sprinkler heads and rust-like spots on handles and hinges in the facility.

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