Nurse Assist, a Texas-based manufacturer of sterile IV saline flush syringes, failed to maintain adequate device history records, perform CAPA actions or control labeling activities, according to an FDA warning letter.
An FDA site inspection, conducted less than two weeks after the firm began recalling some lots in October 2016 over reports of B. cepacia infections, revealed that several cases of its IV saline syringes had not been sterilized.
Also, the device history records for the recalled lots did not include the final quantity of products reviewed, approved and released for distribution.
