FDA Warning Letter: CGMP Violations in Pharmaceutical Manufacturing | BioBoston Consulting 

Discover the recent FDA warning letter issued to a pharmaceutical company for significant CGMP violations. Learn about the key violations, necessary corrective actions, and the importance of adhering to CGMP regulations. 

A recent United States Food and Drug Administration (FDA) warning letter cited a pharmaceutical company for extensive Current Good Manufacturing Practice (cGMP) regulation violations in the area of finished pharmaceuticals. The letter asserted that the adequacy of methods, facilities, or controls for making, processing, packing, or holding did not conform to cGMP and that drug products were therefore adulterated. 

Key CGMP Violations Cited 

In their letter, the FDA cited two primary violations. One of these was a company-level violation: written procedures covering the requirements for separate or defined areas and control systems to prevent contamination combinations were not kept on site. The company made a range of over-the-counter finished drug products, such as toothpaste and mouth rinse drugs containing sodium fluoride, stannous fluoride, and potassium nitrate in the facility on equipment that was used to manufacture many different nonpharmaceutical materials. The FDA determined that these nonpharmaceutical product ingredients could be harmful to drug products produced in shared equipment, which is a violation of cGMP. 

Implications for Pharmaceutical Manufacturing 

In reference to the warning letter, FDA asked the company to cease manufacturing drugs on shared equipment and establish a plan for segregation between their areas with dedicated manufacturing equipment for both pharmaceutical and nonpharmaceutical product manufacturing. The FDA also told the company to do a risk assessment for all drugs that have ever been made on equipment shared with nonpharmaceutical products. 

According to the warning letter, the company also did not test a sample of each component for conformance with all appropriate written specifications for purity, strength, and quality. The company used supplier’s test results for incoming components with no assurance on the reliability of their certificates of analysis (COA). In addition, the firm did not perform testing of components used in their drug products. For instance, there was not an identity test of the company’s diethylene glycol (DEG) and ethylene glycol (EG)-containing batches and containers of all incoming and in-process bulks before using it to manufacture drug products. 

Required Corrective Actions 

The FDA asked the company for a complete third-party assessment of these material systems including the qualification of all suppliers of components, containers, and closures, and appropriate expiration or retest dates as they pertain to materials. The complete response letter also outlined the requirements that they provide a plan for lot-by-lot testing of each component to demonstrate conformity with all applicable specifications for strength, identity, quality, and purity. Either way, the FDA asked that, if the company plans to rely on any results obtained from their supplier’s COAs rather than testing each component lot, strength and purity, they must outline how they will validate their supplier’s test results as reliable through either an initial validation or periodic revalidation. 

Conclusion: Lessons for the Industry 

Consequently, the FDA sent a warning letter to a drug manufacturer for serious cGMP violations observed in their finished pharmaceuticals. The FDA referenced two violations by the company in their letter and called for novel measures to be taken up by them concerning the same. The article ended with a warning to companies processing pharmaceuticals to comply with all the cGMP requirements or experience getting their own version of this series of warnings and potential penalties from the FDA. 

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