More than 135 million bottles of different over-the-counter medicines were recalled in late April because of manufacturing deficiencies at J&J's McNeil Consumer Healthcare Unit plant in Fort Washington, Pa. An investigation by the Food and Drug Administration revealed horrific conditions and processes, including such findings as grime, dust, a hole in the ceiling and bacteria-contaminated raw ingredients. Operations at the plant have been suspended since April as J&J conducted a full review of its manufacturing processes.
But according to FDA investigators, a recent inspection conducted from Oct. 27 through Dec. 9 still revealed problems, most notably, a failure to properly follow customer complaints. An inspection report released Wednesday also made the following observations:
- Control procedures that monitor the output and validate the performance of the manufacturing processes are not established.
- There is a failure to thoroughly review any unexplained discrepancy and failure of a batch or any of its components.
- Records are not maintained that would allow data to be reviewed at least annually to evaluate the quality standards.
- Investigations of a discrepancy and a failure of a batch or any of its components did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
- Written records are not always made of investigations into unexplained discrepancies.
- The responsibilities and procedures applicable to the quality control in it are not fully followed.
The recalls were the subject of two Senate investigations, and the Oversight Committee hearings revealed coverups and phantom recalls. Not only did the recalls tarnish J&J's reputation but they also hurt its financial results: Sales in its consumer health care unit declined a whopping 25% in the last quarter.
McNeil Consumer Healthcare spokesperson Marc Boston told DailyFinance in an emailed statement that "The company has been working diligently to ensure that our manufacturing operations meet the level of quality that consumers and the FDA expect of us, and that we expect of ourselves. 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."
JNJ shares were down 0.37% to $62.34 by 10:30 a.m.