FDA 483 - L. Perrigo Company - September 13, 2007

This FDA Form 483 document details observations from an inspection concerning the sampling and examination of labeling and packaging materials for drug products.

**Observation 1** notes that labeling and packaging materials are not representatively sampled and examined upon receipt and before use. Specifically, for liquid drug dosing cups produced on two equipment lines, the sampling plan failed to represent both lines. This deficiency led to the presence of experimental cups, lacking dosing measures, being found in received batches (e.g., Perrigo batch #'s and ).

**Observation 2** indicates that written procedures for sampling packaging and labeling materials are not followed. SOP " and its associated were not adhered to regarding the selection of six different cavity numbers and the recording of which cup (cavity) mold numbers were inspected for Dosing Cup . Examples provided include supplier batches with manufacturing dates between July 24 and July 31, 2007, and corresponding Perrigo batch receipts and inspection dates between July 25 and August 17, 2007, where these procedures were not followed.