Company: Efoora Inc. dba Virotek LLC
Product: Lancets and inoculating loops
Date: 5/12/04
Your firm failed to validate computer software used as part of the quality system as required by 21 CFR 820.70(i). For example, your firm has no documented validation activities and results for the _____ electronic data management system.
Your firm failed to establish adequate procedures for quality audits as required by 21 CFR 820.22. For example, audits performed of your firm’s quality system failed to determine that the _____ electronic data management system lacked validation. Additionally, quality audits failed to detect that your firm was not consistently following procedures.
FDA District: Chicago District Office
