Nubratori, Inc. dba Nubratori Rx
FDA issued a warning letter to Nubratori, Inc. dba Nubratori Rx, a 503B outsourcing facility in Torrance, CA, following a July 2024 inspection that revealed serious CGMP deficiencies in sterile drug compounding operations. The violations included insanitary conditions (improper glove fingertip sampling), failure to establish adequate acceptance criteria for batch release, inadequate environmental monitoring, and failure to validate component supplier test analyses. FDA found the facility's corrective action responses insufficient due to missing supporting documentation, and warned that failure to adequately address violations may result in seizure or injunction.
Required actions (2)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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