FDA Inspection of API Maker Finds Myriad cGMP Lapses

Fourteen days of FDA inspection of its New Brunswick, N.J., facility in February and March earned Spectrum Laboratory Products a 483 describing yellow streaks on floors, peeling paint on walls and only 58 of 5,679 complaints investigated, among the 14 observations in the FDA’s report.

Investigators found the company, a manufacturer of active pharmaceutical ingredients (API), had failed to minimize cross-contamination in the company’s repackaging operations, with the area lacking procedures or records of maintenance of the air handling system and residue remaining on scales and other interior surfaces after cleaning.

While the packing rooms are designated as ISO 8 control environments, investigators noted that “There are no procedures, qualifications, or monitoring performed to support this area as ISO 8 certified.”

Read the Form 483 here.

To read the whole story, click here to subscribe.

Related Topics