FDA's OK of Perrigo plant signals SOP fixes

The FDA's all-clear sign for Perrigo's Michigan manufacturing plant this week is in some ways an understatement of what must have happened there. Inspectors arrived on March 1 and Perrigo announced its "acceptable regulatory status" on Tuesday, six weeks later.

The re-inspection follows a warning letter from nearly a year ago that cited the generics maker's QC unit for not verifying label accuracy, a step spelled out in the company's standard operating procedures. It also reminded the company that it's been warned before on this count.

"FDA investigators documented your firm's failure to follow standard operating procedures during the last three FDA inspections, as well as in other inspections since 1998," according to the letter.

Two instances of tablet mix-ups related to poor inspection of packaging equipment were cited as well. One involved the discovery of a brown, round Ibuprofen tablet in a lot of brown, oval caplets. The other involved a mixing of orange and brown caplets.

To get the FDA's OK on the plant, Perrigo likely had to revise SOPs and retrain operators, as well as executives unaccustomed to a culture of quality. The latter might have been the hardest part. As CEO Joseph Papa said in a statement, "We are convinced that this process has made us a better company."

- here's Warning Letter 2010-DT-11
- see the Perrigo statement

Suggested Articles

Popular logic says you never switch horses, or CDMOs, in the middle of the stream, but Acacia Pharma had to do that to win an FDA approval.

The FDA has found issues with the testing practices of a U.S. generics maker that had specific problems with ADHD and weight-loss drugs.

A warning letter says Chinese API maker Yibin Lihao Bio-technical was found lying to the FDA about manufacturing unapproved heparin.