The FDA cited GlaxoSmithKline’s East Durham, New York facility for failing to follow standard operating procedures.
In an Aug. 30 and Sept. 11, 2018 inspection, the FDA investigator noted that the facility did not validate its cleaning procedures for manufacturing equipment.
The company also didn’t adhere to its quality system SOP for conducting periodic product reviews. Specifically, the facility failed to complete a timely annual product review for one of its stannous fluoride products, going beyond the one-year time limit and completing it in June 2018.
Some of the firm’s SOPs had overdue review dates, such as a procedure for entering packaging component specifications.