…of an organization that has completely missed the proverbial boat in regards to complying with the QSR; considering most of the basic elements of a QMS are missing such as:…

…the 10 observations commencing with the phrase; “Failure to establish and maintain procedures.” To make matters worse, FDA rejected all 10 of this company’s initial responses with the famous agency…

…of process parameters and component and device characteristics during production; Compliance with specified reference standards or codes; The approval of processes and process equipment; and Criteria for workmanship which shall…

…guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon. FDA’s enforcement page. (2014, May). FDA.gov Website. Retrieved June 4, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm399011.htm….

…into the CAPA system can come from: (a) manufacturing operations; (b) audit reports (internal, external, and supplier); (c) customer complaints; (d) management review meetings; (e) other non-conformances, e.g., product or…

…simplified approach for complying with 21 CFR, Part 820.50. Simply stated; “there is no such thing as minimum compliance and no such thing as maximum compliance; there is just compliance.”…