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Significant deficiencies in the companys quality control unit; laboratory notebooks did not include all raw test data generated during testing; failure to check for accuracy the inputs to and outputs from the Total Chrom Data Acquisition System, which is used to run the firms HPLC instruments; quality control failed to recognize that some tablets that did not meet in-process specifications; lack of adequate procedures for conducting bulk product holding time studies; cleaning validation studies were found to be inadequate; master and batch production and control records were found to be deficient; and equipment used in the manufacture of Benztropine Mesylate tablets and other drug products was not adequately qualified.

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Numerous instances were observed where manufacturing process deviations occurred and in-process specifications were not met, yet there was no indication that action was taken promptly to investigate or to correct the deviations and the products were approved for release and distribution by the quality control unit, the agency wrote. Do not stop using this medication suddenly without first talking to your doctor. Carisoprodol can cause side effects that may impair your thinking or reactions. In the unlikely event you have a serious allergic reaction to this drug, seek immediate medical attention. For example, the requalification of an undisclosed ingredient, which was used in the production of Benztropine Mesylate tablets, batch RBR-2137, did not have clearly defined acceptance criteria.
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