Embattled J&J plant cited again by FDA

FDA inspectors aren't convinced that Johnson & Johnson ($JNJ) is doing enough to fix problems at its troubled Fort Washington, PA, plant. That's the facility that produced the children's drugs caught up in the massive recall earlier this year. Since then, it's been a major focus in J&J's efforts to fix its manufacturing slip-ups, which prompted more than a dozen recent recalls.

But in a recent visit to the McNeil Consumer Healthcare plant, which has been closed for an overhaul since April, FDA inspectors identified a number of quality control problems. The plant's staff didn't handle customer complaints properly, didn't fully review discrepancies in product batches and didn't keep proper records, the inspectors said.

The company says it's toiling to bring its processes up to snuff. In a statement, McNeil said it has been "working diligently to ensure that our manufacturing operations meet the level of quality that consumers and the FDA expect of us. While the company has made progress...this is an ongoing commitment."

Indeed. J&J has been reviewing its manufacturing and quality control companywide, a process that has resulted in a couple of new recalls in the last two months. A plant in Puerto Rico has been another focus of concern, as products made there turned up with a musty, moldy odor and had to be recalled. FDA inspectors have cited that plant for shortfalls as well.

- read the Reuters news

Suggested Articles

Look out, diabetes market: Novo Nordisk won its FDA nod for highly anticipated Rybelsus to control blood sugar in patients with Type 2 diabetes.

Insys is in fire sale mode as part of its bankruptcy plan, and now it’s been given the go-ahead to sell the opioid that helped get it there.

GSK CEO Emma Walmsley could soon have a new title: Microsoft board member. The software giant has nominated her to its board of directors.