FDA Warns California OTC Drugmaker for CGMP Violations

The FDA issued a warning letter to Samson Pharmaceuticals, a Commerce, California OTC drug manufacturer, for serious CGMP violations.

The warning followed up on a Jan. 24 to Feb. 9, 2018 inspection by the agency that revealed the facility failed to properly maintain its aseptic processing areas. The violations included peeling paint on cleanroom walls that risked contamination and damaged floors and cracked walls that made them difficult to clean and disinfect.

The facility also lacked microbial action levels for employees engaged in aseptic operations, with microbial counts on personnel monitoring samples found to be above acceptable levels for the ISO 5 area. The investigator found abnormally high counts on the operators’ gloves and clothing while they manufactured the firm’s eye drop product.