L. Perrigo Company – FDA 483, Jan 14, 2010

This FDA Form 483 was issued to L. Perrigo Co., a drug manufacturer located at 515 Eastern Ave, Allegan, MI, following an inspection from November 17, 2009, to January 14, 2010. Joseph Papa, President and CEO, received the report.

The inspection revealed eight observations:

1. **Reserve drug product samples are not representative of each lot or batch:** Finished packaged tablet drug products, particularly those packaged before June 25, 2009, containing multiple bulk tablet batches under one lot number, lack representative reserve samples. This hinders complaint follow-up, as specific bulk batches from which a complainant's product originated cannot always be assuredly sampled. Numerous examples of APAP 500 mg ETS Tablets, Ibuprofen 200 mg tablets/caplets, and Naproxen Sodium 220 mg Caplets/Tablets were cited, where reserve samples did not adequately represent all bulk lots or customer labels within a finished lot.

2. **Incomplete investigations of unexplained discrepancies:** Investigations into issues like a cracked wastewater pipe leaking into a coating pan or the finding of a foreign tablet in a filler did not extend to other potentially affected batches or products. For instance, a cracked wastewater pipe incident affecting APAP 500 mg caplet batch 9A4360 did not prompt investigation of previous batches in the