FDA 483 - L. Perrigo, Co. - August 10, 2005

The FDA Form 483 inspection revealed several violations at the facility. Drug products failing quality control criteria were not rejected, as seen with Fiber Therapy (S43AC) batch 3M1393, which failed Foreign Matter testing due to green epoxy particles from equipment carts. Despite a lost original sample and a smaller second particle confirming the failure, the lot was released.

Written procedures for equipment cleaning and maintenance were not followed, specifically the "DISPENSING WASH CHECKLIST" from the SOP Dispensing Cleaning Procedure. This checklist was not performed between dispensing dissimilar materials on multiple dates in May, July, and August 2005.

Procedures for warehousing drug products were also not followed. The SOP Monitoring and Recording Temperature Readings at APC was violated, with numerous extended temperature sensor alarms and malfunctions between December 2003 and June 2005, lasting from 2 to 93 days. There was no documentation of evaluation, investigation, maintenance, or an excursion binder for these incidents. Mean Kinetic Temperature calculations included these faulty readings.

Furthermore, written records of major equipment cleaning, maintenance, and use were not included in individual equipment logs. The Bulk Transfer System, used for citric acid and sucrose dispensing, lacked such a log.

Finally, written production and process control procedures were not followed. A deviation for a raw material transfer error noted on October 6, 2004, was not initiated until December 24