FDA Cites Charles River Endosafe Lab Over Quality System Deficiencies

FDA is taking issue with Charles River Laboratories' Endosafe contract testing laboratory in Charleston, SC, over multiple quality system deficiencies following a March inspection that found inadequate controls over laboratory operations, equipment calibration, deviation management, complaint handling and investigation procedures. A just-posted Form FDA 483 lists a single observation with five separate deficiencies.

The laboratory performs contract endotoxin testing for drug products. According to the inspection report, the agency found that the laboratory's quality control responsibilities and procedures "are not in writing and fully followed."

Among the most significant findings, FDA said the quality unit failed to adequately protect laboratory operations from nearby construction activity. Inspectors noted that endotoxin sample preparation and testing continued while construction was underway in an adjoining room despite a change control plan stating construction was not expected to affect laboratory operations.

FDA observed that plastic sheeting separating the laboratory from the construction area contained gaps and that construction personnel temporarily removed the barrier during the inspection, exposing the laboratory to the construction area. Investigators also reported finding dust on the laboratory side of the barrier and on the laboratory floor, while laboratory personnel had installed air purifiers without evaluating their effectiveness under the site's change control procedures. FDA further noted that the laboratory had not documented enhanced cleaning procedures during construction and that managers indicated they were unaware of the potential impact airborne dust could have on sample integrity or endotoxin test results.

The agency also cited the laboratory for using equipment after its calibration had expired. Investigators found that a laboratory weight with a calibration due date of 3/12 remained in use on 3/24 to verify calibration of an analytical balance used to weigh product samples during endotoxin testing. FDA said calibration verification checks had been performed multiple times using the expired weight and that laboratory staff were unaware the weight was overdue for calibration until investigators identified the issue.

FDA additionally criticized the firm's deviation management practices, saying a deviation involving a temperature excursion in a sample storage refrigerator was classified as "minor" even though the deviation report acknowledged a potential impact on qualified equipment and sample storage conditions. Agency investigators noted that the firm's own procedures state deviations affecting equipment should be classified as major or critical.