Unofficial HPLC Injections and Shared Common Login lead to an FDA Warning Letter

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter dated July 23, 2020, to Tender Corporation. The firm manufactures and distributes OTC products. During an inspection from November 12 to 25, 2019, the FDA  investigators observed specific violations of current Good Manufacturing Practice (CGMP).

The FDA reviewed the response to the Form FDA 483 in detail and came to the conclusion, that the company's "quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs" manufactured. In this context, it is remarkable that In previous inspections, dated April to May 2016, and May to June 2018, FDA cited similar CGMP observations.

Unofficial HPLC Injections

During the inspection, analytical records were reviewed. It came out that samples injected on the high performance liquid chromatography (HPLC) system were not included in the laboratory records that were used by your Quality Unit (QU) for batch disposition decisions. The laboratory management could not provide an adequate explanation for these unofficial injections to the FDA investigators.

The FDA summaries the problem as follows: "Unofficial sample injections are not acceptable. All data must be complete, accurate, and retained to enable appropriate assessments and decisions by the QU regarding batch disposition and to demonstrate ongoing control."

Common Log-in and Password for IR Spectrophotometer

Furthermore, the company failed to have the proper controls in place to prevent the unauthorized manipulation of laboratory raw electronic data. According to the FDA, laboratory employees shared a common log-in and password to access the Infrared Spectrophotometer (IR) system.

In response to the Warning Letter, the FDA asked the company to specify all user roles and associated user privileges for all staff levels who have access to the laboratory computer systems and their organizational affiliation and title. In addition, the company must describe in detail how it will ensure that administrative privileges are fully segregated and completely independent of laboratory personnel.

 Test Methods were Not Appropriate for their Intended Use.

The company did not ensure that the test methods were appropriate for their intended use. For example, some methods "resulted in abnormal peaks, missing integration, and required the use of blank injections between samples to prevent carryover". Although several system suitability failures were attributed, no CAPA was initiated. This is not acceptable as "laboratories must establish and validate (or verify, where appropriate) analytical methods and procedures to ensure the robustness and consistency of testing. Likewise, laboratory discrepancies must be thoroughly investigated to make reliable root cause determinations and ensure effective CAPA."

No Adequate Investigations into Drug Product Complaints

According to the FDA, the company lacked adequate investigations into drug product complaints. Multiple complaint investigations were closed without determining a root cause.

Unapproved New Drug and Misbranding Violations

In addition, the FDA also criticizes claims observed on the product labels and on the product websites. Some of the company's products, as formulated and labeled, do not comply with the current regulations and may not be legally marketed in the United States absent approval of an application.

Conclusion

In summary, the FDA came to the conclusion that the quality system of Tender Corporation is inadequate. Based upon the nature of the violations, the FDA recommends engaging a consultant to assist the firm in meeting CGMP requirements.

The complete list of the deficiencies and the recommendations and instructions of the FDA can be found in the Warning Letter for Tender Corporation published on the FDA's website.