New J&J recalls hint at far-reaching QA woes

Issues with the device end a drug/device combination are behind this week's J&J product recall. The healthcare giant is retrieving two lots of prefilled Simponi SmartJect autoinjectors because they may deliver only a portion of the 50-mg (0.5 mL) dose of the rheumatoid arthritis treatment.

Standard quality testing uncovered the flaw. Reuters says J&J has stepped up inspections at plants across all of its business units.

There's no doubt that product quality is receiving unprecedented scrutiny at J&J's McNeil unit, which initiated recalls of some 40 consumer products last year (see our Tylenol Timeline for a sampling). CEO Bill Weldon told CNBC last September that the company had checked all 120 of its manufacturing sites around the world to make sure they didn't have manufacturing and QA problems like those that led to the shutdown of a Pennsylvania plant. He denied the healthcare giant had a "systemic" quality problem.

An ops restructuring last year followed McNeil's raft of recalls affecting primarily Tylenol products. That move put Ajit Shetty in charge of supply chain for J&J. It essentially re-centralized manufacturing and QA ops, which had previously been decentralized by Weldon.

Late last month, Weldon told investors that J&J had reviewed operations for every McNeil product manufactured in-house, about 80 percent of the portfolio, and was shifting its focus to those made by contractors. He indicated at that time that the increased scrutiny may lead to additional McNeil product recalls. But he made no mention of other J&J units.

J&J makes clear that the Symponi recall is device-specific; it's found no problem with the drug.  Eighty percent of the 839 U.S. pens have been quarantined at the wholesale level. That leaves 165 units in the market for J&J to find.

The company says the Symponi SmartJect fail rate is 0.5 percent. The pre-filled injection devices were made at J&J's Janssen Biologics plant in Switzerland. The recall is being conducted by Centocor Ortho Biotech.

- here's the Reuters report
- see the Simponi notification

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