MMC Healthcare Ltd.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).

Passage 2

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)).

Passage 3

Your firm failed to establish the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).

Passage 4

Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at MMC Healthcare Ltd., 34-B Sidco Industrial Estate, Thirumazhisai, Chennai into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).