FDA 483 - L. Perrigo Company - March 28, 2006

On March 28, 2006, the FDA issued a Form 483 to L. Perrigo Company, a drug manufacturer located at 515 Eastern Ave., Allegan, MI 49010, following an inspection conducted from March 21-28, 2006. The report was issued to John T. Hendrickson, Executive VP and General Manager of Perrigo Consumer Healthcare.

The inspection revealed three observations:

1. **Deficient Complaint Records:** Complaint records lacked complete documentation of investigation findings. Specifically, complaint number (b)(4) dated 02/07/2006, which led to deviation investigation (b)(4), did not include full written documentation of the investigation, including justification for not needing an investigation at the contract manufacturing facility. 2. **Failure to Follow Complaint Handling Procedures:** The firm's Standard Operating Procedure (SOP) (b)(4) dated FEB 16, 2006, for handling drug product complaints, was not completely followed. Complaints opened before but closed after the SOP's effective date, such as (b)(4) opened 10/24/05 and closed 03/13/06, and PCA (b)(4) opened 01/20/06 and closed 03/13/06, did not include the