L. Perrigo Company – FDA 483, Dec 15, 2006

This FDA Form 483, issued to L. Perrigo Company, an Rx and OTC drug manufacturer in Allegan, MI, on December 15, 2006, following an inspection from November 7 to December 15, 2006, details 19 observations.

Key violations include: - **Inadequate Investigations:** Investigations into discrepancies (e.g., metal fragments, microbiological contamination, consumer complaints) lacked documented conclusions, follow-up, root cause determination, or extension to other relevant batches/materials. Contract manufacturers were not always notified of complaints. - **Quality Control Deficiencies:** Quality control unit procedures were not fully followed, including statistical evaluation of all packaging configurations, adherence to process capability analysis (Cpk) thresholds, and consistent deviation coding. - **Stability and Expiration Dating:** Reserve samples were not visually examined annually for deterioration, and expiration dates (e.g., 36-month for 500-count bottles of enteric-coated aspirin) were not supported by stability data for the specific package size. - **Equipment and Cleaning:** Written procedures for equipment cleaning and maintenance (e.g., product transfer hoses) were absent or not followed. Equipment cleaning and use logs were not chronological, and major maintenance was not consistently recorded. Cleaning validation for certain equipment/cleaning agents was inadequate. - **Production and Process Control:** Written procedures were not consistently followed (e.g., coating