J&J Puerto Rico Plant Tied to Drug Recalls Still Has Problems: FDA

Johnson & Johnson continues to have quality control problems at a plant in Puerto Rico that was previously found to produce products that failed to meet to federal quality standards, according to a new report by government inspectors. 

FDA investigators have filed a new report on Johnson & Johnson’s Puerto Rico manufacturing facility (pdf) that lists a number of deficiencies and problems that the company has failed to correct over the last year.

The report lists what the inspectors described as recurrent problems in quality control and failures to investigate and root out problems.

The company’s policy of “reverse distribution,” where it purchases products back from wholesalers and retailers without declaring a recall, was criticized in the report. The company allegedly only conducts the practice when there are no quality defects or health issues. However, the FDA said there was at least one recall of Motrin IB where the tactic’s use was questionable. Some lawmakers have referred to the practice as “stealth recalls.”

Inspectors also found that some drugs that failed to meet quality control standards were not rejected as they should have been, and instead were released to the public. Earlier this month, the company announced a recall of 4 million packages of children’s Benadryl and 800,000 bottles of junior-strength Motrin due to the belated realization that they were released after failing to meet manufacturing standards.

Other problems found at the plant include a failure to properly investigate quality discrepancies and why some drugs fail to meet quality control standard; failure of the plant to follow its own written production and process control procedures, as well as procedures for the proper testing and examination of drugs; and failure to establish proper and in-depth procedures for cleaning and maintenance of drug manufacturing equipment.

The inspection covered a period from September to November, and follows up a warning letter the FDA sent to Johnson & Johnson over the plant’s problems in January.

Johnson & Johnson has been under scrutiny since a massive drug recall on April 30, which affected 40 different liquid medication products, including Tylenol, Benadryl and Motrin. That recall affected 136 million bottles of children’s medications, and resulted in the shutdown of the company’s Ft. Washington, Pennsylvania, plant, and the suspension of the production of all children’s medications made by its McNeil Consumer Healthcare subsidiary.

Following that recall, the FDA has received nearly 800 complaints of problems with Tylenol and the other recalled drugs, including at least seven reports of deaths associated with the medication. However, the FDA says its investigations so far have not directly linked any of the recalled products to any of the deaths.

Since then, the company has had a concerning number of recalls, missteps and other problems that have resulted in Congressional hearings and boosted the likelihood that the FDA will receive increased powers to regulate drug makers.

Other incidents that have plagued Johnson & Johnson throughout the year include:

• A recall of 93,000 potentially defective DePuy ASR metal hip implants by its subsidiary, DePuy Orthopaedics.
• Benadryl, Motrin and Tylenol recalls due to contamination by pesticide, leading to a musty smell.
• A $258 million jury verdict over allegations of misleading information over Risperdal health risks and an ongoing Justice Department investigation into allegations of kickback schemes.
• A Velcade recall of 400,000 vials due to particle contamination.
• Another Tylenol recall of 9 million bottles due to labeling that did not properly warn consumers that the drugs contained alcohol.