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The U.S. Food and Drug Administration (FDA) has sent a warning letter to KVK-Tech regarding "significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. The FDA inspection took place in April 2019."
"Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B)," according to inforation provided in the letter.
During the FDA inspection, investigators observed violations that include:
Failure to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).
Failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether the batch has already been distributed (21 CFR 211.192).
Failure 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)).
KVK-Tech has 15 days to respond in writing to the FDA.
The complete letter can be reviewed on the FDA website.