Warning letters: Investigators refused entry to testing lab; firm cited for distributing unauthorized COVID tests

Regulatory NewsRegulatory News | 31 August 2022 |  By 

The US Food and Drug Administration (FDA) chastised a San Diego, California based testing lab in a recent warning letter for “significant deviations” from current good manufacturing practices (GMPs), including initially blocking investigators from entering the site, making false statements, failing to adequately the suitability of its analytical methods for testing products and lacking adequate safeguards over computer equipment.
In another recent warning letter, the agency took a Grapevine, Texas based medical device company to task for distributing unauthorized COVID-19 tests and for committing a litany of other GMP violations.
Refused inspection
Contract testing lab Green Wave Analytical, LLC of San Diego, CA, which tests finished sterile injectable drugs and components, received the 19 August warning letter for “significant deviations” from GMPs.
Even though the firm was given prior notice of the inspection on 10 February, investigators were refused entry to the site for several days when they arrived later in the month. The company also “falsely stated” that it did not perform CGMP testing of finished drug products or components under contract.
On the fourth day of the inspection, the company relented and provided a written statement that it had performed GMP testing in 2020 and 2021 on behalf of a sole customer. Due to these inspection delays, drugs tested at the site were deemed adulterated, said FDA.
After five days, investigators, were finally allowed into the FDA-registered suite of facility. The letter noted five GMP violations, one was 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 was not established.
FDA told the firm that “method validation and verification is necessary to support reliable determinations of identity, strength, quality, purity, and potency of drugs. Without evaluating the validity of methods, you lack the basic assurance that the data provided to customers was an accurate reflection of pharmaceutical product quality.”
Other failures were lack of sufficient controls over its high-performance liquid chromatography (HPLC) system that was used to test drugs prior to release, including the failure to prevent deletion and alteration of raw data files.  FDA said that personnel had administrative privileges to the operating software for the HPLC equipment and were able to delete data sequences and change method parameters.
Audit trails were missing that record 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 tests were conducted and the reasons for the action.
The firm also failed to validate electronic signatures used to approve analytical testing records for releasing drugs from January 2020 to September 2021.
The firm has since de-registered and is no longer performing GMP testing of drugs, nor do they have any plans to resume future testing, FDA said.
FDA warns firm for marketing unauthorized COVID test
Another recent warning letter targeted USA Medical LLC for distributing unapproved, uncleared, and unauthorized SARS-CoV-2 Antigen Rapid Test kits. These products lacked an approved premarket approval application (PMA) or investigational device exemption (IDE).
These products are also misbranded because of “false” and “misleading” statements that they are authorized for use under an Emergency Use Authorization (EUA). FDA told the firm that “none of your COVID-19 Test Kits have been approved, cleared, or authorized for emergency use by FDA.”
FDA investigators also cited the firm for 12 GMP violations, among them: failure to establish procedures for acceptance activities. Other problems were failing to prevent mix-ups and contamination of products, failing to establish procedures for corrective and preventative action and failing to establish procedures for reviewing and evaluating complaints.
Green Wave Analytical, LLC
USA Medical LLC


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Tags: FDA, GMPs, letters, warning

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