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January 21, 2020
21
Jan

Warning Letter – Lack of manufacturing controls

January 21, 2020
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Tismor Health and Wellness Pty Limited, FEI 3008932054, at 19a Garema Cct, Kingsgrove, from May 20 to 24, 2019. This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211. Because your...
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