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Article: Carton Services slapped with 4-item 483 for failing to perform required equipment challenges.(HUMAN DRUGS)
- Article from:
- Inspection Monitor
- Article date:
- September 1, 2005
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Carton Services, Norris, TN, New Orleans District
Carton Services, Norris, TN, was hit with a four-item 483 because it failed to perform SOP-required equipment challenges, and for failing to follow protocol during validation studies.
FDA documents stated that 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 packaging, the EIR stated, the company performs challenges of some equipment, such as, testing the ability of an undisclosed machine to detect errors. Such ...