The regulator called Sato Yakuhin Kogyo’s response inadequate in a warning letter on its site this week explaining that, in addition to establishing an electronic records system in its quality lab, the firm needs to conduct a retrospective analysis.
The Food and Drug Administration (FDA) also raised concerns about Sato Yakuhin Kogyo’s efforts to ensure the reanalysis of out of specification (OOS) product samples is documented, explaining the firm needs to “describe the role of the quality unit in this procedure.”
The agency added that: “Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. We strongly recommend that you retain a qualified consultant to assist in your remediation.”