Tablet mix-ups and a failure to reject a lot of ibuprofen pills contaminated with metal shavings have earned Perrigo Warning Letter 2010-DT-11. In addition, the generics maker's QC unit failed to verify label accuracy, a violation of its operating procedures.
The deviation from SOPs likely sounded familiar to CEO Joseph Papa. The letter says: "FDA investigators documented your firm's failure to follow Standard Operating Procedures (SOPs) during the last three FDA inspections, as well as in other inspections since 1998."
The warning follows a late 2009/early 2010 inspection. It cites two instances of tablet mix-ups. One involved a round, brown ibuprofen tablet discovered in a lot of oval brown caplets. The other involved a mixing of orange and brown caplets. With the metal shavings, Perrigo operators had seen them, but they segregated just a portion of the lot, and then shipped some of those segregated. A recall of the entire lot followed.
To Perrigo's credit, it corrected the violations and passed a re-inspection in March, earning an "acceptable regulatory status" finding from the FDA.