A Food and Drug Administration report on a dozen recent inspections of a Johnson & Johnson plant that produced non-prescription medicines for heart burn and other health problems details a list of violations that could undermine the quality of the company’s products.
According to the preliminary report, the Lancaster, Pa., factory failed to investigate problems that could affect the composition of its drugs and did not adequately maintain equipment. Inspectors also faulted the plant for lax record-keeping, and for not checking some medicine batches that were produced during equipment failures.
Officials said they had to ask for information as many as 10 times before they were provided with the requested materials.
Johnson & Johnson has faced scrutiny for quality control issues in recent months. The company has issued eight recalls of over-the-counter medicines since September, and in April the FDA shut down a Fort Washington, Pa., plant that produced Tylenol and other drugs. The shutdown and recalls are expected to cost the company $600 million this year, The Associated Press reports.
In a statement, Johnson & Johnson said that it “takes the issues raised by the agency seriously.”
The FDA said it is still working on a final report.
“There has been no determination as to next steps or further action at this time,” an agency spokesperson said.


