J&J faces FDA scrutiny for another manufacturing unit

Another Johnson & Johnson subsidiary has come under scrutiny by FDA for failing to meet quality standards in its manufacturing.

Advanced Sterilization Products, part of J&J's Ethicon subsidiary which makes devices used in surgery, failed to meet current Good Manufacturing Practice (cGMP) standards at a plant in Irvine, California which was inspected by the US regulator last year.

A warning letter posted on the FDA's website on 25 May (but dated 12 March 2010) indicates that after reports that some of the steriliser products made at the plant exhibited defects - such as emitting oil mist and hydrogen peroxide - ASP did not implement effective actions to correct the faults or indeed check that those actions were working.

At the end of March, Ethicon also informed the FDA that sutures made by the company were released into the supply chain prior to sterilisation, raising the risk of infections if they were used in patients.

McNeil outlines recovery plans

Meanwhile, J&J's consumer health unit McNeil Consumer Healthcare has set out its plans for getting its manufacturing operations back into regulatory compliance after having to recall several paediatric products because of quality issues.

McNeil has hired an independent consultancy firm to help bring its manufacturing facility in Fort Washington back up to speed. Manufacturing at the facility has been suspended in the wake of the recall, which involved widely-used paediatric health products including liquid formulations of Tylenol (acetaminophen), the antihistamine Zyrtec (cetirizine), cough medicine Benadryl (diphenhydramine) and painkiller Motrin (ibuprofen).

It also said it had initiated improved processes and employee training in its manufacturing and quality operations, along with "significant organisational changes", although it did not go into details.

"McNeil is taking steps to bring its operation back to a level of quality that J&J demands of its companies, and that the public rightly expects of us, and that we expect of ourselves," said the company in a statement.

The recall of paediatric health products was the catalyst for Congressional hearings on J&J's GMP compliance problems which are scheduled to take place today (27 May) with a senior McNeil executive in attendance.

Phil Taylor