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FDA issues Warning Letter to a Pharmaceutical Company for Significant CGMP Violations

Updated: Feb 15


The United States Food and Drug Administration (FDA) recently issued a warning letter to a pharmaceutical company for significant violations of the Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The letter stated that the methods, facilities, or controls for manufacturing, processing, packing, or holding did not conform to CGMP, which rendered the drug products adulterated.

The United States Food and Drug Administration (FDA) recently issued a warning letter to a pharmaceutical company for significant violations of the Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The letter stated that the methods, facilities, or controls for manufacturing, processing, packing, or holding did not conform to CGMP, which rendered the drug products adulterated.


The FDA cited two main violations in their letter. The first violation was that the company failed to have separate or defined areas or control systems necessary to prevent contamination or mix-ups. The company manufactured finished drug products, including toothpaste and mouth rinse products containing sodium fluoride, stannous fluoride, and potassium nitrate using the same equipment used to manufacture numerous nonpharmaceutical materials. The FDA found that the ingredients in the nonpharmaceutical products could contaminate the drug products manufactured on shared equipment, which is unacceptable as a matter of CGMP.


In response to the warning letter, the FDA requested that the company discontinue manufacturing drugs on shared equipment and provide a plan to separate the areas in which they maintain dedicated manufacturing equipment for their pharmaceutical and nonpharmaceutical product manufacturing operations. Additionally, the FDA requested a risk assessment for all drugs previously produced on equipment shared with nonpharmaceutical products.


The second violation cited in the warning letter was that the company failed to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality. The company relied on certificates of analysis (COA) for incoming components from suppliers without establishing the reliability of the suppliers’ test results. Furthermore, the company lacked appropriate testing of components used in the manufacture of their drug products. For example, the company lacked a specific identity test to detect diethylene glycol (DEG) and ethylene glycol (EG) in all shipments, containers, and lots of glycerin before use in the manufacturing of drug products.


The FDA requested that the company provide a comprehensive, independent review of their material system to determine whether all suppliers of components, containers, and closures are each qualified and the materials are assigned appropriate expiration or retest dates. Additionally, the FDA requested a description of how the company will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If the company intends to accept any results from their supplier’s COAs instead of testing each component lot for strength, quality, and purity, the FDA requested the company specify how they will establish the reliability of their supplier’s results through initial validation as well as periodic revalidation.


In conclusion, the FDA issued a warning letter to a pharmaceutical company for significant violations of CGMP regulations for finished pharmaceuticals. The FDA cited two main violations in their letter, and requested that the company take specific actions to address the violations and prevent future occurrences. Companies in the pharmaceutical industry should take note of this warning and ensure that they comply with all CGMP regulations to avoid similar warnings and potential penalties from the FDA.

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