Wexford Labs was cited in a three-observation Form 483 over supposedly lax quality control procedures.
The document accuses the company of failing to establish sanitary procedures, neglecting to conduct internal audits of its quality control processes and disregarding training procedures. These accusations stem from a Jan. 6 to 7 inspection of the company’s plant in Kirkwood, Mo.
The agency’s first complaint is that the company lacks the necessary procedures to ensure sterility in equipment and products. According to the FDA, Wexford had no established procedure for cleaning stainless steel mixing tanks. Personnel said that product-specific tanks “are almost never cleaned.” Additionally, the 483 noted that the tanks also lack closing lids to prevent foreign materials from entering them.
The 483 also noted that Wexford has yet to conduct internal audits as specified in the company’s operating procedures and internal audit schedule.
Lastly, the inspector contended that the company lacks a procedure to govern training and a matrix for identifying employee training needs.