The plant operated by McNeil Consumer Healthcare, a unit of the Johnson & Johnson conglomerate, recalled millions of bottles of over the counter drugs, including Tylenol and Motrin, in January, The New York Times reported Saturday.
Johnson & Johnson also recalled 136 million bottles of liquid children's Tylenol and other medicines in April, although these were made in Pennsylvania, the Times said.
The McNeil plant in Puerto Rico was cited in a recently posted Food and Drug Administration inspection report for failure to detect and identify quality control issues and distributing products that did not meet quality control standards. The FDA also cited the plant for failure to follow laboratory procedures, and for products with incorrectly labeled expiration dates.
"Clearly, this inspection shows that the company continues to have serious quality control issues at its plant and that it is not in compliance with current good manufacturing practices required by federal law," said FDA spokeswoman Karen Riley Friday.
In a statement, McNeil said it was working with the FDA to make improvements and would continue to cooperate to address the problems not yet corrected.
"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," the statement said.