FDA warning letters cite STI testing failures, facilities with animal feces, and a researcher who overdosed autistic children

The US Food and Drug Administration (FDA) has published recent warning letters to a fertility clinic for not properly screening donors for sexually transmitted infections (STI), a drug compounder and a homeopathic drugmaker for maintaining insanitary conditions, and a clinical investigator for overdosing autistic children on the investigational drug.

On 1 July, FDA published several new warning letters, including one to an Illinois-based fertility clinic, InVia Fertility Specialists. The clinic was cited for several violations including failing to test human cells, tissues, and cellular and tissue-based products (HCT/P) from reproductive donors for possible infections. It was also cited for not checking donor medical records for potential risk factors.

“For example, anonymous oocyte donor [redacted] was not tested for human immunodeficiency virus, type 1 (HIV-1), hepatitis C virus (HCV), and hepatitis B virus (HBV) by the [redacted] method,” said the agency. “HCT/Ps were recovered from this donor on April 15, 2024, and transferred to a recipient.”

FDA investigators also said InVia failed to properly conduct donor screening, label HCT/Ps from ineligible donations, and establish proper procedures to test and screen donors.

In a separate letter, Indian drugmaker Healwell Homeo Private Limited was cited for maintaining insanitary conditions at its manufacturing facility where it produces over-the-counter (OTC) homeopathic medicines. FDA inspectors found rodent and bird excrement, black mold-like material, insects, and loitering dogs near entryways. They also found certain products used in manufacturing were stored outdoors in dirty drums.

In addition to the insanitary conditions, FDA said Healwell violated several CGMP requirements, including failing to test and validate the components used in drug manufacturing.

“You failed to adequately test samples of your incoming components before using them to manufacture your [redacted] and OTC drug products,” said FDA. “During the inspection, you informed the investigator that you reviewed certificates of analysis (COAs) for incoming materials, but did not perform identity testing, did not verify the supplier COA, and did not have a quarantine or approval process.

“Furthermore, you used [redacted] as a component in some of your drug products… You stated that you did not test this [redacted] prior to use in production,” the agency added. “It is unacceptable to not conduct identity testing on a drug component, especially knowing it is labeled as another component.”

FDA said Healwell’s quality unit failed to provide adequate oversight of its manufacturing, including proper documentation, validation of production and process controls, and maintenance of cleaning procedures. Agency officials said they tried but failed to contact Healwell following its inspection to initiate a recall of its products and ultimately ended up contacting its distributor to stop marketing its products in the US.

“After the inspection, FDA made multiple unsuccessful attempts to schedule a teleconference with you to recommend removing your drug products from the US market,” said FDA. “On April 2, 2025, FDA held a call with your distributor, [redacted], to provide notice of the conditions at your facility and recommend market action. On April 8, 2025, [redacted] initiated a recall of products manufactured at your facility, currently in US distribution.”

A third letter cited Nebraska-based drug compounder Staska Pharmaceuticals for insanitary conditions. The agency said its inspectors found that drugs that were meant to be sterile were prepared, packaged, or held in insanitary conditions where they may have become contaminated.

The company was also cited for using a bulk substance from an unregistered facility and for violating section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA), because its drugs did not include labeling information regarding adverse event reporting and directions for use.

"Because your compounded drug products have not met all of the conditions of section 503B, they are not eligible for the exemptions in that section from the FDA approval requirements of section 505, the requirement under section 502(f)(1) that labeling bear adequate directions for use, and the Drug Supply Chain Security Act requirements described in section 582 of the FDCA," said FDA.

More broadly, FDA found that the facility failed to meet the agency's CGMP requirements. For instance, it said Staska failed to investigate unexplained discrepancies or batch failures and their components. The company was also cited for failing to establish proper quality control procedures, ensure the staff was adequately trained, and ensure a system to monitor environmental conditions.

FDA furthermore cited Staska for marketing unapproved and misbranded new drug products.

"You compound drug products that are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses," said the agency. "Consequently, their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA."

While Staska responded to FDA's Form 483 outlining its corrective action plans, FDA said it couldn't evaluate the plan due to a lack of documentation, such as documentation to ensure quality assurance staff are properly trained and how it plans to conduct quality risk assessments.

Finally, FDA also published a warning letter citing a Florida-based clinical investigator for failing to follow the investigational plan. More specifically, Peter Michael, of M.D./G+C Research Group, was cited for giving at least twice the amount of the investigational drug to two children for several weeks.

“According to the protocol, the maximum dose allowed for these subjects was 1.5 mg/day,” said FDA. “As a result, Subjects [redacted] and [redacted] received daily doses of [redacted] that exceeded the daily dose allowed by the protocol.

“Specifically, Subjects [redacted] and [redacted] received twice the maximum daily dose of study drug for at least 16 and 22 days, respectively, which exposed them to an increased risk of adverse events,” the agency added.

While Michael wrote back to FDA with a corrective and preventive action plan (CAPA), the agency said it lacked sufficient information. The agency wants more details on the training and procedures he plans to implement to prevent future violations.

“Given the significance of the protocol violation involving pediatric subjects, we request follow-up documentation regarding the training and procedures implemented at your site to ensure compliance with study protocol dosing procedures,” said FDA. “Without this information, we are unable to determine if your corrective action plan is adequate to prevent similar violations in the future.

“Your failure to conduct the clinical study in accordance with the protocol resulted in an overdose of investigational drug to pediatric subjects,” the agency added. “This conduct raises significant concerns about your protection of the study subjects enrolled at your site and raises concerns about the validity and integrity of the data collected at your site.”

Invia Fertility Specialists; Staska Pharmaceuticals; Healwell Homeo; Michael Peter

FDA warning letters cite STI testing failures, facilities with animal feces, and a researcher who overdosed autistic children

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