J&J plant quality shortcomings disclosed in FDA report

FDA inspection report revealed that Johnson & Johnson’s Lancaster, Pa., plant failed to investigate and fix problems when consumers filed complaints that “foreign materials, black or dark specks” were found in medicine bottles.

Consumers complained about finding mixed up flavors and kinds of Pepcid tablets in the same bottle from June 2009 to April 2010.

The Lancaster plant, owned by J&J and Merck & Co. Inc., produces over-the-counter medications such as the heartburn medications Pepcid and Mylanta.  

When FDA inspectors sought records concerning drug quality-control issues, they faced unnecessary delays, according to the inspection report released on Wednesday. They said information as basic as an organization chart for the plant, which industry standards say should be readily accessible, had to be requested many times before receiving full information.

The report identified 12 shortcomings at the plant during the inspection between June 22 and July 9 including unavailability of records, inadequate procedures for properly cleaning equipment, and failure to adequately follow through on consumer complaints.

The Lancaster plant endured a string of recalls of various over-the-counter medicines due to quality issues.

On Wednesday, J&J plant officials issued a statement that it will take the issues raised by the FDA seriously and will address the concerns as quickly as possible.

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