FDA warns clinical investigator for research violations, device firm over unapproved surgical masks

In two recent compliance actions, the US Food and Drug Administration (FDA) issued warning letters to a clinical investigator for a litany of violations tied to a clinical trial involving Takeda’s Hyqvia and Gammagard Liquid and to a medical device maker for marketing unapproved face masks and surgical masks.

In its warning letter issued to clinical investigator Konrad Rejdak, FDA cited the researcher for failing to maintain accurate patient records and for faulty record keeping following a four-day inspection in May 2023 at the investigator’s site in Lublin, Poland.

FDA inspectors found fault with how Rejdak conducted the Phase III study evaluating the efficacy and safety of Takeda’s drug Hyqvia and Gammagard Liquid for treating chronic inflammatory demyelinating Polyradiculoneuropathy (CIDP), an autoimmune disease. The drug was approved by FDA in January 2024.

FDA said that Rejdak failed to keep records of clinical trials studies and manually entered in the data months after the study was conducted. For example, in “multiple instances,” subject ability assessment scores were not entered into the company’s electronic system and one of these assessments measured drug efficacy.

Investigators also found there were gaps, some as long as 25 days, between the assessment and the date the assessment was entered into the system. In addition, there was no documentation for 144 assessment values for four subjects over the course of nine visits.

Rejdak attributed the delay to a poor internet connection during the COVID-19 pandemic. FDA said the response was inadequate because it “contradicts what was relayed by both sub investigators during the inspection.” In addition, these patient visits occurred before the start of the pandemic, said FDA.

Rejdak has 15 days to notify FDA of any actions taken to resolve the deficiencies cited in the warning letter.

When asked by Focus to comment on the warning letter, a Takeda representative said the company excluded the efficacy data from this site in their approval of the of the drug.

“We were aware of the U.S. Food and Drug Administration (FDA)’s inspection observations related to one of the clinical trial sites of the ADVANCE-CIDP clinical program. We collaborated with the FDA to address the findings, and our approved prescribing labels for HYQVIA and GAMMAGARD LIQUID ultimately excluded efficacy data from this clinical trial site. We are confident in the safety and efficacy analyses from our ADVANCE-CIDP clinical research program, which are based on results from more than 80 different research sites around the globe.”

Baylab USA cited for marketing unapproved face masks

FDA also issued a warning letter to Baylab USA in Dallas TX for marketing unapproved versions of its face masks and surgical masks. At issue is the company’s 3-ply surgical ASTM Level 3 masks, ASTM Level 1 Baylab 3-ply ear loop face masks, and KN95 respirator.

FDA inspectors said the company’s ASTM Level 1 mask, its KN95 respirator, and certain versions of its ASTM Level 3 mask are adulterated. The ASTM Level 3 Mask is misbranded because the firm made “major changes” without submitting a new premarket notification or 510(k) for new colors of the mask.

While the company’s ASTM Level 3 Mask was approved for use in “bay blue” under a 510(k) submission for adult use and is “intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material” and to “reduce the potential exposure to blood and body fluids.”

During the inspection, it was found that the ASTM Level 3 Mask is offered in multiple colors and in pediatric sizes that were not included in the initial 510(k) submission. The firm’s website also marketed its ASTM Level 3 Mask in non-approved colors including “silver surf,” “admiral navy,” “orca black,” “seafoam green,” “sea lavender,” “coral pink,” and “white tide.” The website also offered the “Kids ASTM Level 3 Mask,” “Anti-Fog ASTM Level 3 Mask,” as well as special edition models with printed logos including, but not limited to, “Breast Cancer Awareness,” “Love,” and “Summer” masks without proper marketing authorization.

FDA states that “the additional colors, materials, and expansion of the user population constitute significant changes or modifications that require a premarket notification. For example, the introduction of new materials, including new colors (colorants) and printed logos, are changes or modifications that could significantly affect the safety or effectiveness of the device in that they may alter the chemistry of the final device.”

The warning letter also chastised the company for making unsubstantiated claims in the labeling and its website for its ASTM Level 1 Mask and KN95 respirator. The labeling includes statements claiming, “bacterial filtration efficiency,” “particle filtration efficiency,” and “fluid resistance,” and the label collected for the KN95 respirator contained a statement claiming, “filtration efficiency against solid and water-based particulates.”

On its website, the company says the masks provide at least 95% particulate or bacterial filtration efficiency and fluid resistance at 80 mmHg and are fluid resistant. FDA said that “based on these claims, these products are intended for use in the diagnosis of diseases or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body.” Yet the company did not seek premarket approval (PMA) to make these claims.

The company has 15 days to respond to the warning letter.

Warning letter to Konrad Rejdak; Warning letter to Baylab

FDA warns clinical investigator for research violations, device firm over unapproved surgical masks

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