483
Professional Compounding Centers of America dba PCCAProfessional Compounding Centers of America dba PCCA – FDA 483, Apr 21, 2023
Record Details
Professional Compounding Centers of America dba PCCA, an API Repacker/Relabeler in Houston, TX, was cited for three significant observations. These included failures in maintaining appropriate environmental conditions to prevent contamination during repackaging, inadequate transfer of API manufacturer information to customers, and deficiencies in the quality unit's investigation and resolution of critical deviations. The findings indicate serious concerns regarding product quality and safety.
- Inspection date
- April 21, 2023
- Product type
- drugs
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ID · cfe1029c-d112-4e11-83b8-e258de53a297
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