Warning letters: Investigators denied entry to test lab; company cited for distributing without authorization

Regulatory News

| August 31, 2022 | By Joanne S. Eglovitch

The U.S. Food and Drug Administration (FDA) reprimanded a San Diego, Calif.-based testing lab in a recent warning letter for “significant deviations” from current good manufacturing practices (GMPs), including initially preventing investigators from entering the site, making false statements, failing to adequately verify the suitability of its analytical methods for testing products, and not having adequate safeguards on computer equipment.

In another recent warning letter, the agency blamed a Grapevine, Texas-based medical device company for distributing unauthorized COVID-19 tests and committing a litany of other breaches of the law. GMP.

Inspection denied

Contract testing laboratory Green Wave Analytical, LLC of San Diego, Calif., which tests finished sterile injectable drugs and their components, received the August 19 warning letter for “significant deviations” from GMP.

Although the company was notified of the inspection on February 10, investigators were denied access to the site for several days when they arrived later that month. The company also “falsely stated” that it does not perform CGMP testing on finished pharmaceuticals or contract components.

On the fourth day of the inspection, the company relented and provided a written statement stating that it had performed GMP testing in 2020 and 2021 on behalf of a single client. Because of these inspection delays, drugs tested at the site were found to be tampered with, the FDA said.

After five days, investigators were finally allowed to enter the FDA-registered suite of facilities. The letter listed five GMP violations, one of which was the failure to establish and document the accuracy, sensitivity and specificity of the analytical method used to test the product. For example, even though the test deviated from compendial methods, the suitability of its assay test for the active ingredient phenobarbital sodium has not been established.

The FDA told the company that “method validation and verification are necessary to enable reliable determinations of drug identity, strength, quality, purity, and potency. Without assessing the validity of methods, you lack basic assurance that the data provided to customers accurately reflects the quality of pharmaceutical products.

Other failures were the lack of sufficient controls over its high-performance liquid chromatography (HPLC) system that was used to test drugs before release, including the failure to prevent deletion and modification of raw data files. . The FDA said staff had administrative privileges on the HPLC equipment operating software and were able to delete data sequences and change method parameters.

It lacked audit trails that recorded information about each analytical test, such as the type of injection, the date and time of the injection, the identity of the analyst, and the nature of the action taken after the tests have been carried out and the reasons for the action.

The company also failed to validate electronic signatures used to approve analytical testing records for drug release from January 2020 to September 2021.

The company has since deregistered and no longer performs GMP testing of the drugs, nor does it intend to resume future testing, the FDA said.

FDA warns company for marketing unauthorized COVID test

Another recent warning letter targeted USA Medical LLC for distributing unapproved, unauthorized, and unlicensed SARS-CoV-2 antigen rapid test kits. These products did not have an approved premarket approval (PMA) or investigational device exemption (IDE) application.

These products are also mislabeled due to “false” and “misleading” claims that their use is authorized under an Emergency Use Authorization (EUA). The FDA told the company that “none of your COVID-19 test kits have been approved, cleared, or cleared for emergency use by the FDA.”

FDA investigators also cited the company for 12 GMP violations, including: failure to establish procedures for acceptance activities. Other issues were failure to prevent product mix-ups and contamination, failure to establish procedures for corrective and preventive actions, and failure to establish procedures for the review and assessment of complaints.

Green Wave Analytics, LLC

United States Medical LLC

© 2022 Society of Regulatory Affairs Professionals.


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