Fort Worth drugmaker CBI Laboratories was slapped with a Form 483 for multiple violations at its facility including a flawed quality unit, the lack of annual product reviews and a failure to conduct cleaning validations.
An agency inspection of the facility, which also operates as a contract manufacturer, noted one repeat observation from a previous inspection. The firm didn’t complete process validation studies for OTC topical drug products it began manufacturing in December 2017.
The firm’s quality assurance unit approved two records that included certificates of analyses for a tinted moisturizer that had incorrect assay data reported for titanium dioxide and zinc oxide, the agency found. The unit also failed to conduct a full investigation of three confirmed out-of-specification incidents and didn’t determine their root cause.