The FDA warned supplement manufacturer Sanapac for GMP violations, adulterated products and misbranding following two inspections in late 2016.
FDA officials inspected the company’s Philadelphia facility in late November and again in early December. They found numerous problems at the facility, including the lack of written procedures for quality control operations and failure to provide documentation for promised corrective actions.
Inspectors also found the company did not prepare a master manufacturing record identifying specification points throughout the manufacturing process and the records the company did keep did not meet the agency’s requirements.
The company also failed to keep batch production records for each instance of supplement batch packaging and labeling, and those batch production records it did keep did not accurately follow the master manufacturing record.