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The agency sent a warning letter to Kalchem International for CGMP violations found at the company’s Lindsay, OK, facility.
FDA sent a warning letter, dated Aug. 27, 2020, to Kalchem International after an inspection of the company’s Lindsay, OK, facility found violations of current good manufacturing practices (CGMPs). The inspection was conducted from February 10–21, 2020.
Specifically, according to FDA, the company shipped drug product before receiving the certificate of analysis with assay results from its contract laboratory and batch records were reviewed and approved after the batch was released. The agency requested in the warning letter that the company provide FDA with a list of chemical and microbial specifications used to analyze product batches, an assessment of the company’s laboratory practices and procedures, and a remediation plan to ensure the company’s quality unit (QU) properly functions.
The warning letter also stated that the company’s QU failed to adequately ensure that API met CGMP requirements. Records were not maintained and reviewed for each API that was relabeled, according to FDA. Re-packaging batch records were also not adequately reviewed before release. “For example, one lot of Lidocaine HCL was re-packaged with an incorrect lot number and shipped. Your QU reviewed the Chemical Repackaging record six days after the product had been shipped. The error was not detected until the FDA investigator found it during our inspection,” the letter stated. FDA asked the company to provide a risk assessment of the hazards of inadequate documentation and oversight of relabeled drugs.