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# Optikem CGMP Violations Cited
- URL: https://www.fdaweb.com/optikem-cgmp-violations-cited/
- Published: 2024-07-09T12:00:00.000Z
- Updated: 2026-09-14T14:34:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157308

A 1/17-1/26 FDA inspection at the Optikem International drug manufacturing facility in Denver, CO, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/20 Warning Letter says specific violations were:

- failure to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other controls necessary to prevent contamination or mix-ups in aseptic processing areas;
- failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
- failure to establish adequate written procedures for production and process control designed to assure that the drug products the company manufactures have the identity, strength, quality, and purity they purport or are represented to possess;
- failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components conform to appropriate standards of identity, strength, quality, and purity, and to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms; and
- failure 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 and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.

FDA says Optikem’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs the company manufactures. It recommends the company retain a qualified independent third-party consultant to assist it in data remediation. The letter reminds Optikem of its responsibility as a contractor to manufacture drugs following CGMP. It recommends that Optikem engage a qualified consultant to assist in meeting CGMP requirements.

The company was told to correct violations promptly and to respond with a list of specific steps it has taken to address violations and prevent their recurrence, with a schedule for completing the corrections.