Packager slapped with 4-item 483 for failing to follow protocol during several validation studies.

Carton Services, Norris, TN, was hit with a four-item 483 because it did not follow protocol during validation studies.

According to FDA documents, Carton Services manufactures paperboard cartons, some of which contain pharmaceutical or dietary supplement labeling. The firm also performs some repackaging and relabeling of pharmaceutical and dietary supplement products.

During validation, the FIR stated, protocol procedures "were not always followed and some failures to meet acceptance criteria were noted." The final report was approved even though some follow-up actions and revalidations were required, the report continued. Also, "no formal controls are in place to assure these follow-up actions will be completed," the FIR stated. Next, the final report concluded that an undisclosed machine speed had not been documented.

According to the FIR "the various protocol documents provided very little information on how equipment was to be set up and speeds at which equipment was to be run during the OQ [operational qualification] study." Also, Maticka wrote that he "asked what set-up instructions the operators had to work with at the time the OQ study was performed. Management stated they did not have anything in writing. This was considered objectionable."

The FDAer also cited Carton Services because PQ [performance qualification] batches were released by concurrent validation, although the company's procedures for process validation "describe no ...