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mercredi 13 novembre 2019
WARNING LETTER Swabplus, L.P. MARCS-CMS 584803 — OCTOBER 31, 2019
4. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).
Your firm failed to have adequate controls in place for your High-Performance Liquid Chromatography (HPLC) and Fourier Transform Infrared Spectrometer (FTIR) systems. For example, you did not establish unique user names for each analyst. Additionally, you did not properly maintain backup copies of your original data from your laboratory equipment.
In your response, you stated that your systems were “legacy equipment” incapable of an appropriate backup. Your response is inadequate because your firm lacked a comprehensive assessment and retrospective review of all data generated from all computerized laboratory systems used in CGMP operations...