FDA Warning Letter for Chinese OTC Hand Sanitizer Drug Products Manufacturer

Recommendation

24/25 April 2024

QC Compliance Manager - Live Online Training

On 18 October 2022, the U.S. Food and Drug Administration (FDA) has published a Warning Letter dated 05 October 2022 to a manufacturer in Beijing, China. The firm manufactures over-the-counter (OTC) hand sanitizer drug products.

During an inspection from 11 to 15 April 2022, the FDA investigators found a whole series of GMP violations, including identity testing, cleaning and maintenance of equipment, microbial testing and QU oversight.

Identity Testing

According to the FDA, the company failed to adequately test the incoming components for identity before using it to manufacture the drug products. Thus, it was not ensured that the components meet the appropriate specifications.

The company had provided test methods for APIs used in manufacturing, as well as test results in the response to the Form FDA 483 that preceded the Warning Letter. However, this answer was not sufficient for the FDA, as the company has "not provided details for the associated test methods for [the] active ingredients and components demonstrating that [the] test methods are equivalent to or better than United States Pharmacopeia (USP) methods."

Cleaning and Maintenance of Equipment

Obviously, the company uses the same equipment to manufacture drug products as for non-drug industrial product.

In this regard, the FDA states the following: "It is unacceptable as a matter of CGMP to continue manufacturing drugs using the same equipment that you use to manufacture industrial products due to the risk of cross-contamination."

Microbial Testing

The batch record reviewed by the FDA investigators indicated that no microbial testing on the finished hand sanitizer drug products was performed. Therefore, it was not ensured that the appropriate microbial quality specifications were met.

Process Validation

According to the Warning Letter, the company failed to validate the manufacturing processes. Critical manufacturing variables were not sufficiently identified, and it was not demonstrated that the "processes were controlled to consistently yield a drug product of uniform character and quality."

QU Oversight

The FDA writes that the company's quality unit (QU) did not provide adequate oversight for the manufacture of the OTC drug products. This is shown, among others, by the fact that the batch records were not signed by the QU, and that the QU could not locate the laboratory test results in the electronic system.

Conclusion

Against the background of the deficiencies identified, the FDA considers the company's quality systems as inadequate. The FDA has placed the firm on Import Alert 66-40 (Detention without physical Examination of Drugs from Firms which have not met Drug GMPs).

In the Warning Letter, the FDA provides an extended list of measures to be taken to remediate the GMP deficiencies. This includes

• a retrospective risk assessment on the impact of the lack of adequate tests for incoming components;
• a risk assessment for all drugs that were previously produced on equipment shared with industrial products;
• an action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States;
• a summary of the validation program;
• a timeline for performing appropriate process performance qualification for each marketed drug products;
• a plan to ensure that the QU is given the authority and resources to effectively function;
• a complete assessment of the documentation systems.

As long as the measures are not taken, the FDA won't withdraw the Import Alert on the company's products.

To find out more details, please see the Warning Letter issued to Beijing Xinggu Lvsan Technology Co., Ltd. Formerly known as Beijing Lvsan Technology Co., Ltd.