Between January and September 2010, the FDA notes that McNeil received 49 consumer complaints of product-mix-ups. The problems were noted during a recent inspection of McNeil's drug making facility in Puerto Rico, CNN reports. Eight of the violations were reported in October.
The violations include a lack of safeguards to isolate 'rejected' raw materials and drugs, human error resulting in product mix-ups, and inadequate quality control.
In January 2010 millions of units of Tylenol, Motrin and Benadryl were recalled from the market because of reports of moldy, musty smelling product. Further recalls followed in July 2010.
"It appears that the company has failed to correct certain quality control and procedural problems documented in prior inspections and cited in a January 2010 warning letter to the company," FDA spokesman Christopher Kelly said in an e-mail to CNNMoney.
Johnson & Johnson CEO William Weldon and other top J&J executives have faced two congressional hearings about the recalls.
The FDA investigation of J&J's 'comprehensive action plan' to fix its production problems remains ongoing.