Shortly after J&J’s OTC manufacturing site in Fort Washington, Pennsylvania was closed after a US Food and Drug Administration (FDA) inspection in 2010, a lawsuit was filed by shareholders accusing J&J of cutting back on quality control measures at the site.
Though admitting no wrongdoing in a court filing last week, J&J has agreed to pay a $22.9m (€17.4m) settlement closing a chapter of recalls and manufacturing violations at the site.
J&J spokesperson Samantha Lucas told in-Pharmatechnologist.com the facility is “on track to be ready for certification at the end of this year,” adding that once certified the plant can reopen.
In January 2010, the FDA issued a warning letter to J&J’s McNeil Consumer Healthcare Unit who ran the facility. Furthermore, a ‘musty’ odour attributed to the presence of trace amounts of 2,4,6-tribromoanisole – a chemical used to treat wooden pallets in transport and drug storage – led to the recall of US lots of J&J’s Tylenol over the counter (OTC) painkiller.
An inspection of the plant in April 2010 led to the shutdown of operations due to a number of GMP violations. These included contamination of raw materials, lack of quality notification following the rejection of contaminated lots, failure to monitor manufacturing processes and failure to take action against 46 customer complaints it received “regarding foreign materials” found in products
A follow up inspection later that year identified further quality control problems, leading to a consent decree.
Manufacturing Back on Track?
Though recalls continue to haunt J&J – including another 19 lots of Tylenol made from a Brazilian site in May – the firm has undergone a quality initiative inspecting its global manufacturing network, according to statements made in last week’s Q2 2013 earnings results.
“We have gone through all of our manufacturing facilities,” Sandra Peterson, Group Worldwide Chairman, told stakeholders, as part of three-year cycle to ensure “consistent quality standards.”
“We have identified corrective actions and we have immediately taken those corrective actions. We are harmonizing systems. We are putting in place processes and systems so that we have early warning.”
She also said that a number of warning letters had been closed out and “very good progress” is being made on the remaining ones.
According to the company’s annual report, J&J and its subsidiaries operate 146 manufacturing facilities worldwide – 51 in the US and 43 in Europe.
Peterson also said J&J has begun inspecting its external manufacturers under the same scrutiny as its own sites.
In doing so, the number of CMOs (contract manufacturing organisations) has been reduced by about a third, she continued, helping the firm “manage them much more effectively” and ensuring quality of their products coming into J&J’s facilities.
The policy is similar to that of Roche’s management of third-party manufacturers. Recently the firm told this publication its high vigilance, hands on approach ensured a leaner, more secure network but was not evidence of turning its back on outsourcing.