WL Tismor Health and Wellness Pty Limited MARCS-CMS 588104 — DECEMBER 05, 2019
1. 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 contract manufactures over-the-counter (OTC) topical drug products (b)(4). Your firm lacked sufficient controls over your gas chromatography (GC) instrument used to test the drug product prior to release. Specifically, your firm assigned administrative privileges to analysts conducting routine assay tests using your Empower chromatography software data system.
During the review of your Empower chromatography audit trail for your drug product, our investigator observed that you deleted more than 100 test results since October 2017. You also aborted more than 100 sample set results during this same period, although you lacked investigations...
3. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
Your firm failed to validate the Excel spreadsheet used to perform the assay calculation for your “(b)(4).” Your procedures lacked guidance on how to check and manually verify the calculation sheets. During the inspection, our investigator identified a calculation error within the spreadsheet. The incorrect formula for averaging the Internal Standard peak area was used.
There is no assurance that the associated assay results recorded are reliable and accurate...
