According to a report released yesterday, the Food and Drug Administration (FDA) team identified multiple quality control problems during a visit to the facility in November.
Foremost among these was a failure to handle customer complaints about a recalled batch of the over the counter painkiller Tyelnol that was produced at the plant by J&J’s subsidiary McNeil Consumer Healthcare.
The report also flagged up a lack of control procedures and monitoring during the production of McNeil’s Benadryl Allergy Fast Melt range, which the inspectors suggested may be responsible for batch to batch variations.
The FDA goes on to identify problems in record keeping at the facility as another deficiency, specifically a failure to log OOT results during the manufacture of Sudafed PE Cold and Cough tablets.
The plant, which has been at the centre of a number of product recalls over the last 12 months, was closed in April after the FDA lapses in quality control, including thick dust and grime, and contaminated ingredients.
In response McNeil, which has previously said it plans to reopen the facility next year, told Reuters that it is “working diligently to ensure that our manufacturing operations meet the level of quality that consumers and the FDA expect of us."
It added that “While the company has made progress toward that goal, this is an ongoing commitment and we will invest all necessary resources in order to achieve it."